Lower risk Medical device recall · FDA · Published July 18, 2023
Abbott Medical Proclaim Plus 5 Implantable Pulse Generator: MRI Mode Exit Issues
Abbott Medical recalls Proclaim Plus 5 Implantable Pulse Generators (REF 3670) due to patients being unable to exit MRI (Magnetic Resonance Imaging) mode. This device is used for spinal cord stimulation and may require specific MRI safety checks.
Lower-risk recall
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Contact the company
Recalling firmAbbott Medical6901 Preston Rd · Plano, TX 75024-2508
What happened, in plain English
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (REF 3670) because some patients report being unable to exit MRI (Magnetic Resonance Imaging) mode. This device is used for spinal cord stimulation and may pose risks during MRI scans. Read more at govinfonow.com/recall/57632-abbott-medical-proclaim-plus-5-implantable-pulse-generator-mri-mode.
Source Summary by GovInfoNow · govinfonow.com/recall/57632-abbott-medical-proclaim-plus-5-implantable-pulse-generator-mri-mode · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2507-2023
Cite this page
“Abbott Medical Proclaim Plus 5 Implantable Pulse Generator: MRI Mode Exit Issues.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/57632-abbott-medical-proclaim-plus-5-implantable-pulse-generator-mri-mode. Based on FDA recall #Z-2507-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2507-2023%22&limit=1).
Why it’s dangerous
The device may not properly exit MRI mode, which could lead to safety issues during MRI scans. However, the hazard is not described as causing immediate injury or death in normal use.
Who’s affected
Patients with spinal cord stimulation implants using this specific model (Proclaim Plus 5) are most at risk. The recall affects individuals who have this device implanted for spinal cord stimulation.
How to tell if you have this one
Check if your device has the model number 3670 and serial numbers starting with US AAD135.1 through AAD209.1 or other listed serial numbers. This device is used for spinal cord stimulation.
- Brand
Abbott Medical- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2505-2023 | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD337.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP039.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 AAP123.1 AAP128.1 AAP130.1 AAP131.1 AAP136.1 AAP138.1 AAP141.1 AAP142.1 AAP143.1 AAP145.1 AAP151.1 AAP154.1 AAP155.1 AAP156.1 AAP158.1 AAP161.1 AAP163.1 AAP169.1 AAP170.1 AAP171.1 AAP181.1 AAP184.1 AAP204.1 AAP206.1 AAP210.1 AAP222.1 AAP232.1 AAP240.1 AAP241.1 AAP245.1 AAP247.1 AAP248.1 AAP249.1 AAP257.1 AAP258.1 AAP262.1 AAP265.1 AAP272.1 AAP284.1 AAP287.1 AAP296.1 AAP304.1 AAP306.1 AAP309.1 AAP312.1 AAP316.1 AAP317.1 AAP320.1 AAP322.1 AAP323.1 AAP335.1 AAP337.1 AAP340.1 AAP341.1 AAP343.1 AAP344.1 AAP348.1 AAP349.1 AAP357.1 AAP360.1 AAP370.1 AAP378.1 AAP379.1 AAP383.1 AAP384.1 AAP388.1 AAP404.1 AAP405.1 AAP406.1 AAP408.1 AAT455.1 AAT456.1 AAT464.1 AAT466.1 AAT467.1 AAT471.1 AAT489.1 AAT494.1 AAT495.1 AAT502.1 AAT503.1 AAT511.1 AAT515.1 AAT517.1 AAT519.1 AAT521.1 AAT524.1 AAT525.1 AAT526.1 AAT527.1 AAT529.1 AAT531.1 AAT536.1 AAT537.1 AAT539.1 AAT541.1 AAT544.1 AAT548.1 AAT550.1 AAT563.1 AAT569.1 AAT570.1 AAT574.1 AAT578.1 AAT583.1 AAT598.1 AAT600.1 AAT601.1 AAT602.1 AAT606.1 AAT609.1 AAT615.1 AAT616.1 AAT620.1 AAT625.1 AAT627.1 AAT628.1 AAT629.1 AAT638.1 AAT639.1 AAT640.1 AAT645.1 AAT648.1 AAT672.1 AAT675.1 AAT678.1 AAT682.1 AAT687.1 AAT688.1 AAT692.1 AAT696.1 AAT704.1 AAT715.1 AAT716.1 AAT724.1 AAT725.1 AAT729.1 AAT737.1 AAT755.1 AAT756.1 AAT759.1 AAT760.1 AAT764.1 AAT771.1 AAT778.1 AAT794.1 AAT798.1 AAT821.1 AAT829.1 AAT836.1 AAT848.1 AAT855.1 AAT869.1 AAT874.1 AAT877.1 AAT879.1 AAT882.1 AAT883.1 AAT897.1 AAT903.1 AAT908.1 AAT918.1 AAT923.1 AAT931.1 AAT935.1 AAT941.1 AAT942.1 AAT945.1 AAT949.1 AAT952.1 AAT955.1 AAT957.1 AAT961.1 AAT963.1 AAT964.1 AAT965.1 AAT971.1 AAT975.1 AAT983.1 AAT991.1 AAT992.1 AAT993.1 AAT996.1 AAT997.1 AAU001.1 AAU004.1 AAU015.1 AAU024.1 AAU048.1 AAU054.1 AAU070.1 AAU077.1 AAU079.1 AAU091.1 AAU098.1 AAU105.1 AAU107.1 AAU115.1 AAU116.1 AAU129.1 AAU135.1 AAU151.1 AAU153.1 AAU160.1 ABA936.1 ABA937.1 ABA959.1 ABA965.1 ABA970.1 ABA971.1 ABA980.1 ABA982.1 ABA984.1 ABA988.1 ABA991.1 ABA993.1 ABB003.1 ABB004.1 ABB013.1 ABB018.1 ABB019.1 ABB021.1 ABB023.1 ABB024.1 ABB027.1 ABB030.1 ABB031.1 ABB034.1 ABB036.1 ABB043.1 ABB055.1 ABB064.1 ABB072.1 ABB076.1 ABB099.1 ABB100.1 ABB101.1 ABB102.1 ABB107.1 ABB116.1 ABB122.1 ABB134.1 ABB148.1 ABB155.1 ABB156.1 ABB169.1 ABB175.1 ABJ132.1 ABJ133.1 ABJ135.1 ABJ137.1 ABJ143.1 ABJ144.1 ABJ145.1 ABJ151.1 ABJ153.1 ABJ154.1 ABJ158.1 ABJ159.1 ABJ162.1 ABJ171.1 ABJ172.1 ABJ173.1 ABJ176.1 ABJ185.1 ABJ187.1 ABJ192.1 ABJ194.1 ABJ199.1 ABJ201.1 ABJ202.1 ABJ210.1 ABJ218.1 ABJ219.1 ABJ223.1 ABJ227.1 ABJ232.1 ABJ235.1 ABJ240.1 ABJ251.1 ABJ254.1 ABJ256.1 ABJ258.1 ABJ263.1 ABJ264.1 ABJ266.1 ABJ268.1 ABJ276.1 ABJ277.1 ABJ278.1 ABJ283.1 ABJ289.1 ABJ290.1 ABJ297.1 ABJ305.1 ABJ307.1 ABJ319.1 ABJ322.1 ABJ326.1 ABJ327.1 ABJ330.1 ABJ331.1 ABJ337.1 ABJ339.1 ABJ343.1 ABJ347.1 ABJ351.1 ABJ353.1 ABJ355.1 ABJ357.1 ABJ363.1 ABJ367.1 ABJ368.1 ABJ373.1 ABJ377.1 ABJ379.1 ABJ384.1 ABJ385.1 ABJ391.1 ABJ396.1 ABJ397.1 ABJ400.1 ABJ401.1 ABJ402.1 ABJ408.1 ABJ412.1 ABJ414.1 ABJ415.1 ABJ422.1 ABJ434.1 ABJ443.1 ABJ447.1 ABJ450.1 ABJ452.1 ABJ457.1 ABJ460.1 ABJ466.1 ABJ467.1 ABJ471.1 ABJ474.1 ABJ476.1 ABJ482.1 ABJ486.1 ABJ490.1 ABJ492.1 ABJ494.1 ABJ495.1 ABJ499.1 ABJ500.1 ABJ507.1 ABJ508.1 ABJ509.1 ABJ513.1 ABJ516.1 ABJ537.1 ABJ539.1 ABJ550.1 ABJ553.1 ABJ555.1 ABJ557.1 ABJ560.1 ABJ561.1 ABJ562.1 ABJ569.1 ABJ585.1 ABJ590.1 ABJ591.1 ABJ596.1 ABJ597.1 ABJ598.1 ABJ599.1 ABJ602.1 ABJ608.1 ABJ610.1 ABJ619.1 ABJ620.1 ABJ625.1 ABJ626.1 ABJ627.1 ABM159.1 ABM160.1 ABM161.1 ABM163.1 ABM168.1 ABM169.1 ABM171.1 ABM172.1 ABM173.1 ABM179.1 ABM183.1 ABM189.1 ABM192.1 ABM194.1 ABM195.1 ABM197.1 ABM198.1 ABM199.1 ABM201.1 ABM209.1 ABM210.1 ABM212.1 ABM215.1 ABM217.1 ABM218.1 ABM220.1 ABM221.1 ABM222.1 ABM225.1 ABM226.1 ABM228.1 ABM231.1 ABM236.1 ABM247.1 ABM248.1 ABM249.1 ABM261.1 ABM265.1 ABM268.1 ABM269.1 ABM270.1 ABM271.1 ABM274.1 ABM285.1 ABM290.1 ABM295.1 ABM298.1 ABM302.1 ABM303.1 ABM307.1 ABM311.1 ABM315.1 ABM316.1 ABM323.1 ABM328.1 ABM335.1 ABM346.1 ABM347.1 ABM351.1 ABM355.1 ABM359.1 ABM361.1 ABM364.1 ABM375.1 ABM386.1 ABM388.1 ABM395.1 ABM410.1 ABM413.1 ABM422.1 ABM425.1 ABM430.1 ABM434.1 ABM443.1 ABM444.1 ABM445.1 ABM446.1 ABM448.1 ABM450.1 ABM451.1 ABM452.1 ABM455.1 ABM457.1 ABM461.1 ABM463.1 ABM464.1 ABM465.1 ABM467.1 ABM474.1 ABM477.1 ABM481.1 ABM484.1 ABM489.1 ABM490.1 ABM491.1 ABM492.1 ABM493.1 ABM494.1 ABM498.1 ABM500.1 ABM501.1 ABM502.1 ABM503.1 ABM505.1 ABM506.1 ABM508.1 ABM510.1 ABM512.1 ABM519.1 ABM521.1 ABM527.1 ABM528.1 ABM530.1 ABM532.1 ABM533.1 ABM536.1 ABM542.1 ABM552.1 ABM553.1 ABM558.1 ABM563.1 ABM565.1 ABM570.1 ABM572.1 ABM574.1 ABM579.1 ABM588.1 ABM591.1 ABM594.1 ABM595.1 ABM597.1 ABM602.1 ABM603.1 ABM604.1 ABM607.1 ABM608.1 ABM612.1 ABM613.1 ABM615.1 ABM617.1 ABM625.1 ABM627.1 ABM629.1 ABM631.1 ABM636.1 ABM637.1 ABM638.1 ABM641.1 ABM642.1 ABM644.1 ABM646.1 ABM649.1 ABM653.1 ABM655.1 ABM657.1 ABT683.1 ABT685.1 ABT686.1 ABT690.1 ABT693.1 ABT695.1 ABT700.1 ABT702.1 ABT717.1 ABT726.1 ABT727.1 ABT735.1 ABT738.1 ABT742.1 ABT748.1 ABT751.1 ABT752.1 ABT760.1 ABT762.1 ABT763.1 ABT768.1 ABT771.1 ABT774.1 ABT778.1 ABT784.1 ABT786.1 ABT788.1 ABT789.1 ABT791.1 ABT795.1 ABT796.1 ABT804.1 ABT810.1 ABT817.1 ABT820.1 ABT821.1 ABT824.1 ABT825.1 ABT830.1 ABT835.1 ABT836.1 ABT837.1 ABT838.1 ABT840.1 ABT846.1 ABT849.1 ABT851.1 ABT853.1 ABT861.1 ABT863.1 ABT866.1 ABT869.1 ABT870.1 ABT871.1 ABT872.1 ABT880.1 ABT881.1 ABT882.1 ABT885.1 ABT888.1 ABT893.1 ABT894.1 ABT897.1 ABT903.1 ABT908.1 ABT917.1 ABT918.1 ABT920.1 ABT921.1 ABT924.1 ABT928.1 ABT929.1 ABT935.1 ABT938.1 ABT946.1 ABT950.1 ABT953.1 ABT955.1 ABT958.1 ABT959.1 ABT960.1 ABT965.1 ABT968.1 ABT969.1 ABT970.1 ABT974.1 ABT977.1 ABT979.1 ABT985.1 ABT986.1 ABT988.1 ABU001.1 ABU002.1 ABU007.1 ABU010.1 ABU013.1 ABU015.1 ABU017.1 ABU022.1 ABU023.1 ABU027.1 ABU030.1 ABU031.1 ABU033.1 ABU034.1 ABU045.1 ABU047.1 ABU048.1 ABU050.1 ABU051.1 ABU052.1 ABU053.1 ABU060.1 ABU062.1 ABU064.1 ABU065.1 ABU073.1 ABU075.1 ABU083.1 ABU085.1 ABU092.1 ABU094.1 ABU095.1 ABU097.1 ABU101.1 ABU102.1 ABU105.1 ABU108.1 ABU110.1 ABU113.1 ABU114.1 ABU115.1 ABU116.1 ABU117.1 ABU120.1 ABU123.1 ABU126.1 ABU127.1 ABU128.1 ABU129.1 ABU132.1 ABU138.1 ABU142.1 ABU144.1 ABU147.1 ABU149.1 ABU150.1 ABU152.1 ABU153.1 ABU155.1 ABU156.1 ABU161.1 ABU163.1 ABU165.1 ABU168.1 ABU172.1 ABU173.1 ABU176.1 ACD616.1 ACD629.1 ACD638.1 ACD639.1 ACD642.1 ACD644.1 ACD648.1 ACD654.1 ACD657.1 ACD659.1 ACD664.1 ACD668.1 ACD669.1 ACD670.1 ACD671.1 ACD685.1 ACD691.1 ACD693.1 ACD704.1 ACD706.1 ACD707.1 ACD710.1 ACD714.1 ACD715.1 ACD718.1 ACD729.1 ACD732.1 ACD736.1 ACD739.1 ACD749.1 ACD760.1 ACD761.1 ACD762.1 ACD765.1 ACD769.1 ACD777.1 ACD778.1 ACD784.1 ACD792.1 ACD794.1 ACD796.1 ACD798.1 ACD801.1 ACD806.1 ACD807.1 ACD814.1 ACD818.1 ACD820.1 ACD823.1 ACD825.1 ACD826.1 ACD829.1 ACD830.1 ACD838.1 ACD840.1 ACD841.1 ACD842.1 ACD845.1 ACD850.1 ACD851.1 ACD852.1 ACD853.1 ACD855.1 ACD856.1 ACD858.1 ACD859.1 ACE643.1 ACE644.1 ACE647.1 ACE651.1 ACE653.1 ACE655.1 ACE657.1 ACE658.1 ACE666.1 ACE674.1 ACE676.1 ACE691.1 ACE696.1 ACE698.1 ACE702.1 ACE709.1 ACE716.1 ACE725.1 ACE727.1 ACE738.1 ACE739.1 ACE747.1 ACE756.1 ACE757.1 ACE759.1 ACE762.1 ACE766.1 ACE767.1 ACE768.1 ACE769.1 ACE770.1 ACE782.1 ACE785.1 ACE787.1 ACE788.1 ACE792.1 ACE801.1 ACE806.1 ACE807.1 ACE808.1 ACE822.1 ACE823.1 ACE831.1 ACE834.1 ACE839.1 ACE840.1 ACE846.1 ACE858.1 ACE862.1 ACE863.1 ACE869.1 ACE871.1 ACE874.1 ACE878.1 ACE879.1 ACE880.1 ACE882.1 ACE889.1 ACE896.1 ACE897.1 ACE901.1 ACE903.1 ACE904.1 ACE906.1 ACE908.1 ACE916.1 ACE918.1 ACE921.1 ACE925.1 ACE927.1 ACE930.1 ACE933.1 ACE937.1 ACE953.1 ACE960.1 ACE964.1 ACE967.1 ACE977.1 ACE979.1 ACE982.1 ACE983.1 ACE996.1 ACE997.1 ACE998.1 ACE999.1 ACF007.1 ACF008.1 ACF009.1 ACF011.1 ACF013.1 ACF015.1 ACF023.1 ACF025.1 ACF028.1 ACF038.1 ACF044.1 ACF049.1 ACF056.1 ACF057.1 ACF060.1 ACF061.1 ACF062.1 ACF067.1 ACF068.1 ACF070.1 ACF072.1 ACF074.1 ACF076.1 ACF084.1 ACF088.1 ACF092.1 ACK138.1 ACK147.1 ACK150.1 ACK152.1 ACK153.1 ACK154.1 ACK166.1 ACK167.1 ACK168.1 ACK169.1 ACK170.1 ACK173.1 ACK179.1 ACK181.1 ACK183.1 ACK186.1 ACK187.1 ACK189.1 ACK190.1 ACK193.1 ACK195.1 ACK205.1 ACK208.1 ACK211.1 ACK213.1 ACK215.1 ACK216.1 ACK218.1 ACK219.1 ACK222.1 ACK229.1 ACK232.1 ACK234.1 ACK238.1 ACK242.1 ACK243.1 ACK244.1 ACK249.1 ACK250.1 ACK252.1 ACK261.1 ACK266.1 ACK270.1 ACK281.1 ACK287.1 ACK288.1 ACK295.1 ACK296.1 ACK300.1 ACK301.1 ACK303.1 ACK304.1 ACK305.1 ACK308.1 ACK309.1 ACK313.1 ACK315.1 ACK316.1 ACK319.1 ACK324.1 ACK327.1 ACK333.1 ACK334.1 ACK338.1 ACK339.1 ACK341.1 ACK343.1 ACK347.1 ACK348.1 ACK349.1 ACK351.1 ACK352.1 ACK353.1 ACK354.1 ACK356.1 ACK360.1 ACK364.1 ACK367.1 ACK369.1 ACK373.1 ACK378.1 ACK384.1 ACK392.1 ACK393.1 ACK394.1 ACK396.1 ACK406.1 ACK408.1 ACK412.1 ACK414.1 ACK415.1 ACK416.1 ACK419.1 ACK425.1 ACK432.1 ACK434.1 ACK438.1 ACK439.1 ACK440.1 ACK443.1 ACK444.1 ACK445.1 ACK447.1 ACK450.1 ACK451.1 ACK452.1 ACK460.1 ACK464.1 ACK467.1 ACK471.1 ACK476.1 ACK484.1 ACK493.1 ACK496.1 ACK503.1 ACK505.1 ACK506.1 ACK509.1 ACK513.1 ACK517.1 ACK518.1 ACK527.1 ACK532.1 ACK535.1 ACK548.1 ACK552.1 ACK555.1 ACK556.1 ACK558.1 ACK560.1 ACK562.1 ACK563.1 ACK564.1 ACK565.1 ACK567.1 ACK568.1 ACK570.1 ACK576.1 ACK579.1 ACK585.1 ACK591.1 ACK595.1 ACK597.1 ACK606.1 ACK607.1 ACK608.1 ACK609.1 ACK621.1 ACK624.1 ACK640.1 ACK649.1 ACK668.1 ACK684.1 ACK688.1 ACK693.1 ACK694.1 ACK695.1 ACK703.1 ACK704.1 ACK708.1 ACK713.1 ACK717.1 ACK721.1 ACK728.1 ACK729.1 ACK736.1 ACK738.1 ACK741.1 ACK749.1 ACK753.1 ACK758.1 ACK764.1 ACK769.1 ACK772.1 ACK785.1 ACK813.1 ACK815.1 ACK825.1 ACK826.1 ACK848.1 ACK852.1 ACK853.1 ACK857.1 ACK861.1 ACK875.1 ACK877.1 ACP673.1 ACP693.1 ACP698.1 ACP705.1 ACP711.1 ACP717.1 ACP723.1 ACP734.1 ACP735.1 ACP740.1 ACP743.1 ACP744.1 ACP747.1 ACP748.1 ACP750.1 ACP751.1 ACP754.1 ACP757.1 ACP771.1 ACP772.1 ACP782.1 ACP784.1 ACP796.1 ACP798.1 ACP808.1 ACP814.1 ACP816.1 ACP819.1 ACP823.1 ACP826.1 ACP834.1 ACP841.1 ACP842.1 ACP844.1 ACP845.1 ACP855.1 ACP858.1 ACP867.1 ACP871.1 ACP875.1 ACP876.1 ACP877.1 ACP882.1 ACP886.1 ACP888.1 ACP889.1 ACP895.1 ACP896.1 ACP897.1 ACP903.1 ACP905.1 ACP906.1 ACP914.1 ACT540.1 ACT549.1 ACT552.1 ACT564.1… Full codes in the FDA record | 113,784 devices (U.S.-95,226; OUS-18558) |
| Z-2506-2023 | Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 3662 UDI-DI Codes: 05415067031426 05415067020222 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 AAP040.1 AAP044.1 AAP047.1 AAP049.1 AAP053.1 AAP054.1 AAP055.1 AAP056.1 AAP059.1 AAP060.1 AAP062.1 AAP069.1 AAP075.1 AAP079.1 AAP081.1 AAP082.1 AAP083.1 AAP089.1 AAP092.1 AAP093.1 AAP094.1 AAP099.1 AAP100.1 AAP106.1 AAP109.1 AAP113.1 AAP115.1 AAP117.1 AAP118.1 AAP119.1 AAP122.1 AAP124.1 AAP125.1 AAP129.1 AAP133.1 AAP134.1 AAP135.1 AAP139.1 AAP144.1 AAP146.1 AAP148.1 AAP157.1 AAP160.1 AAP162.1 AAP166.1 AAP167.1 AAP168.1 AAP173.1 AAP174.1 AAP176.1 AAP179.1 AAP182.1 AAP185.1 AAP190.1 AAP196.1 AAP199.1 AAP202.1 AAP203.1 AAP209.1 AAP211.1 AAP212.1 AAP213.1 AAP214.1 AAP216.1 AAP219.1 AAP221.1 AAP223.1 AAP225.1 AAP228.1 AAP229.1 AAP230.1 AAP233.1 AAP234.1 AAP242.1 AAP243.1 AAP252.1 AAP260.1 AAP261.1 AAP263.1 AAP264.1 AAP268.1 AAP270.1 AAP274.1 AAP275.1 AAP277.1 AAP278.1 AAP280.1 AAP281.1 AAP283.1 AAP285.1 AAP286.1 AAP288.1 AAP289.1 AAP290.1 AAP292.1 AAP294.1 AAP301.1 AAP302.1 AAP305.1 AAP308.1 AAP310.1 AAP311.1 AAP313.1 AAP315.1 AAP319.1 AAP321.1 AAP325.1 AAP326.1 AAP334.1 AAP336.1 AAP338.1 AAP342.1 AAP346.1 AAP351.1 AAP354.1 AAP358.1 AAP359.1 AAP365.1 AAP368.1 AAP372.1 AAP382.1 AAP386.1 AAP389.1 AAP390.1 AAP396.1 AAP411.1 AAT449.1 AAT450.1 AAT452.1 AAT453.1 AAT457.1 AAT460.1 AAT461.1 AAT463.1 AAT465.1 AAT470.1 AAT472.1 AAT473.1 AAT474.1 AAT477.1 AAT479.1 AAT482.1 AAT483.1 AAT484.1 AAT485.1 AAT486.1 AAT487.1 AAT490.1 AAT492.1 AAT504.1 AAT514.1 AAT522.1 AAT523.1 AAT532.1 AAT533.1 AAT538.1 AAT543.1 AAT547.1 AAT552.1 AAT553.1 AAT555.1 AAT559.1 AAT560.1 AAT561.1 AAT562.1 AAT564.1 AAT566.1 AAT568.1 AAT573.1 AAT584.1 AAT594.1 AAT597.1 AAT599.1 AAT608.1 AAT612.1 AAT614.1 AAT617.1 AAT619.1 AAT622.1 AAT624.1 AAT632.1 AAT633.1 AAT635.1 AAT636.1 AAT641.1 AAT642.1 AAT644.1 AAT647.1 AAT649.1 AAT650.1 AAT651.1 AAT653.1 AAT654.1 AAT656.1 AAT659.1 AAT662.1 AAT666.1 AAT669.1 AAT670.1 AAT671.1 AAT673.1 AAT676.1 AAT679.1 AAT680.1 AAT684.1 AAT689.1 AAT690.1 AAT693.1 AAT695.1 AAT697.1 AAT698.1 AAT699.1 AAT700.1 AAT701.1 AAT703.1 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AAU027.1 AAU030.1 AAU033.1 AAU035.1 AAU036.1 AAU038.1 AAU042.1 AAU045.1 AAU050.1 AAU053.1 AAU058.1 AAU060.1 AAU061.1 AAU062.1 AAU065.1 AAU066.1 AAU069.1 AAU072.1 AAU076.1 AAU081.1 AAU082.1 AAU083.1 AAU085.1 AAU088.1 AAU089.1 AAU092.1 AAU093.1 AAU099.1 AAU100.1 AAU101.1 AAU102.1 AAU104.1 AAU106.1 AAU109.1 AAU111.1 AAU118.1 AAU119.1 AAU120.1 AAU121.1 AAU123.1 AAU127.1 AAU132.1 AAU133.1 AAU134.1 AAU136.1 AAU137.1 AAU139.1 AAU140.1 AAU141.1 AAU145.1 AAU147.1 AAU149.1 AAU150.1 AAU152.1 AAU154.1 AAU157.1 AAU158.1 AAU159.1 AAU161.1 AAU164.1 AAU165.1 AAU166.1 AAU168.1 AAU169.1 AAU170.1 ABA930.1 ABA931.1 ABA932.1 ABA934.1 ABA938.1 ABA939.1 ABA941.1 ABA944.1 ABA947.1 ABA949.1 ABA951.1 ABA953.1 ABA954.1 ABA955.1 ABA956.1 ABA961.1 ABA967.1 ABA969.1 ABA973.1 ABA975.1 ABA977.1 ABA979.1 ABA981.1 ABA983.1 ABA986.1 ABA987.1 ABA992.1 ABA996.1 ABA997.1 ABA999.1 ABB006.1 ABB009.1 ABB014.1 ABB025.1 ABB026.1 ABB032.1 ABB033.1 ABB038.1 ABB039.1 ABB041.1 ABB044.1 ABB045.1 ABB047.1 ABB050.1 ABB054.1 ABB057.1 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ABJ350.1 ABJ356.1 ABJ358.1 ABJ361.1 ABJ364.1 ABJ369.1 ABJ375.1 ABJ378.1 ABJ380.1 ABJ387.1 ABJ398.1 ABJ399.1 ABJ403.1 ABJ404.1 ABJ405.1 ABJ407.1 ABJ409.1 ABJ413.1 ABJ416.1 ABJ417.1 ABJ419.1 ABJ420.1 ABJ423.1 ABJ424.1 ABJ426.1 ABJ429.1 ABJ431.1 ABJ438.1 ABJ441.1 ABJ451.1 ABJ459.1 ABJ462.1 ABJ468.1 ABJ481.1 ABJ496.1 ABJ498.1 ABJ511.1 ABJ512.1 ABJ518.1 ABJ520.1 ABJ521.1 ABJ522.1 ABJ523.1 ABJ524.1 ABJ525.1 ABJ527.1 ABJ529.1 ABJ531.1 ABJ532.1 ABJ533.1 ABJ545.1 ABJ567.1 ABJ572.1 ABJ583.1 ABJ588.1 ABJ593.1 ABJ594.1 ABJ595.1 ABJ600.1 ABJ604.1 ABJ607.1 ABJ613.1 ABJ616.1 ABJ617.1 ABJ621.1 ABJ623.1 ABJ630.1 ABM165.1 ABM170.1 ABM174.1 ABM176.1 ABM177.1 ABM180.1 ABM190.1 ABM191.1 ABM193.1 ABM202.1 ABM203.1 ABM204.1 ABM206.1 ABM207.1 ABM208.1 ABM214.1 ABM216.1 ABM223.1 ABM224.1 ABM229.1 ABM230.1 ABM232.1 ABM233.1 ABM235.1 ABM238.1 ABM239.1 ABM240.1 ABM246.1 ABM250.1 ABM252.1 ABM253.1 ABM255.1 ABM258.1 ABM259.1 ABM262.1 ABM264.1 ABM266.1 ABM275.1 ABM276.1 ABM277.1 ABM279.1 ABM281.1 ABM283.1 ABM292.1 ABM294.1 ABM299.1 ABM300.1 ABM301.1 ABM304.1 ABM305.1 ABM318.1 ABM320.1 ABM321.1 ABM322.1 ABM325.1 ABM332.1 ABM333.1 ABM336.1 ABM340.1 ABM341.1 ABM342.1 ABM350.1 ABM354.1 ABM356.1 ABM365.1 ABM366.1 ABM367.1 ABM368.1 ABM369.1 ABM372.1 ABM374.1 ABM376.1 ABM377.1 ABM378.1 ABM379.1 ABM380.1 ABM383.1 ABM384.1 ABM390.1 ABM391.1 ABM393.1 ABM394.1 ABM398.1 ABM401.1 ABM402.1 ABM403.1 ABM405.1 ABM406.1 ABM417.1 ABM418.1 ABM421.1 ABM429.1 ABM433.1 ABM435.1 ABM436.1 ABM437.1 ABM440.1 ABM441.1 ABM449.1 ABM454.1 ABM456.1 ABM458.1 ABM470.1 ABM473.1 ABM479.1 ABM480.1 ABM483.1 ABM488.1 ABM495.1 ABM497.1 ABM499.1 ABM507.1 ABM509.1 ABM513.1 ABM514.1 ABM515.1 ABM516.1 ABM526.1 ABM529.1 ABM531.1 ABM534.1 ABM538.1 ABM543.1 ABM548.1 ABM550.1 ABM560.1 ABM562.1 ABM564.1 ABM567.1 ABM568.1 ABM571.1 ABM573.1 ABM582.1 ABM583.1 ABM586.1 ABM587.1 ABM590.1 ABM596.1 ABM598.1 ABM599.1 ABM610.1 ABM618.1 ABM623.1 ABM626.1 ABM628.1 ABM632.1 ABM634.1 ABM643.1 ABM645.1 ABM647.1 ABM648.1 ABM650.1 ABT691.1 ABT694.1 ABT696.1 ABT698.1 ABT699.1 ABT701.1 ABT718.1 ABT719.1 ABT723.1 ABT729.1 ABT731.1 ABT734.1 ABT741.1 ABT747.1 ABT755.1 ABT756.1 ABT758.1 ABT759.1 ABT764.1 ABT765.1 ABT766.1 ABT769.1 ABT772.1 ABT780.1 ABT781.1 ABT782.1 ABT783.1 ABT790.1 ABT792.1 ABT801.1 ABT813.1 ABT815.1 ABT819.1 ABT823.1 ABT826.1 ABT831.1 ABT833.1 ABT842.1 ABT845.1 ABT855.1 ABT856.1 ABT857.1 ABT858.1 ABT859.1 ABT864.1 ABT865.1 ABT868.1 ABT875.1 ABT876.1 ABT879.1 ABT886.1 ABT889.1 ABT890.1 ABT891.1 ABT895.1 ABT896.1 ABT901.1 ABT904.1 ABT905.1 ABT907.1 ABT909.1 ABT911.1 ABT912.1 ABT933.1 ABT936.1 ABT939.1 ABT941.1 ABT943.1 ABT949.1 ABT951.1 ABT957.1 ABT964.1 ABT966.1 ABT971.1 ABT972.1 ABT976.1 ABT978.1 ABT987.1 ABT993.1 ABT994.1 ABT995.1 ABT999.1 ABU009.1 ABU012.1 ABU016.1 ABU019.1 ABU025.1 ABU029.1 ABU032.1 ABU037.1 ABU038.1 ABU039.1 ABU041.1 ABU044.1 ABU046.1 ABU054.1 ABU055.1 ABU059.1 ABU067.1 ABU072.1 ABU074.1 ABU086.1 ABU087.1 ABU090.1 ABU091.1 ABU098.1 ABU109.1 ABU111.1 ABU112.1 ABU118.1 ABU122.1 ABU124.1 ABU125.1 ABU136.1 ABU137.1 ABU139.1 ABU140.1 ABU148.1 ABU151.1 ABU158.1 ABU159.1 ABU166.1 ABU167.1 ABU169.1 ABU171.1 ABU178.1 ABU180.1 ABU182.1 ACD618.1 ACD625.1 ACD633.1 ACD636.1 ACD637.1 ACD641.1 ACD646.1 ACD647.1 ACD651.1 ACD653.1 ACD658.1 ACD660.1 ACD661.1 ACD662.1 ACD672.1 ACD673.1 ACD679.1 ACD680.1 ACD688.1 ACD692.1 ACD700.1 ACD708.1 ACD717.1 ACD720.1 ACD723.1 ACD726.1 ACD727.1 ACD734.1 ACD735.1 ACD737.1 ACD738.1 ACD740.1 ACD742.1 ACD743.1 ACD744.1 ACD751.1 ACD753.1 ACD754.1 ACD755.1 ACD756.1 ACD759.1 ACD786.1 ACD787.1 ACD788.1 ACD804.1 ACD808.1 ACD816.1 ACD817.1 ACD824.1 ACD827.1 ACD831.1 ACD832.1 ACD837.1 ACD843.1 ACD847.1 ACE645.1 ACE659.1 ACE663.1 ACE668.1 ACE671.1 ACE672.1 ACE673.1 ACE678.1 ACE686.1 ACE687.1 ACE694.1 ACE701.1 ACE703.1 ACE704.1 ACE707.1 ACE710.1 ACE711.1 ACE712.1 ACE713.1 ACE715.1 ACE717.1 ACE718.1 ACE720.1 ACE724.1 ACE726.1 ACE728.1 ACE729.1 ACE730.1 ACE731.1 ACE733.1 ACE734.1 ACE736.1 ACE737.1 ACE746.1 ACE748.1 ACE754.1 ACE755.1 ACE761.1 ACE765.1 ACE773.1 ACE775.1 ACE781.1 ACE789.1 ACE793.1 ACE797.1 ACE798.1 ACE799.1 ACE802.1 ACE803.1 ACE804.1 ACE805.1 ACE810.1 ACE815.1 ACE816.1 ACE817.1 ACE818.1 ACE820.1 ACE825.1 ACE826.1 ACE830.1 ACE833.1 ACE841.1 ACE842.1 ACE844.1 ACE845.1 ACE847.1 ACE851.1 ACE853.1 ACE855.1 ACE859.1 ACE861.1 ACE866.1 ACE870.1 ACE872.1 ACE885.1 ACE886.1 ACE890.1 ACE891.1 ACE895.1 ACE902.1 ACE923.1 ACE924.1 ACE928.1 ACE932.1 ACE934.1 ACE941.1 ACE945.1 ACE946.1 ACE951.1 ACE952.1 ACE955.1 ACE957.1 ACE958.1 ACE963.1 ACE965.1 ACE966.1 ACE968.1 ACE972.1 ACE975.1 ACE976.1 ACE978.1 ACE985.1 ACE988.1 ACE989.1 ACE993.1 ACF012.1 ACF016.1 ACF020.1 ACF021.1 ACF029.1 ACF031.1 ACF033.1 ACF034.1 ACF036.1 ACF041.1 ACF050.1 ACF051.1 ACF052.1 ACF053.1 ACF059.1 ACF066.1 ACF069.1 ACF071.1 ACF077.1 ACF078.1 ACF079.1 ACF080.1 ACF081.1 ACF083.1 ACF086.1 ACF087.1 ACF089.1 ACF090.1 ACF093.1 ACK134.1 ACK137.1 ACK142.1 ACK156.1 ACK157.1 ACK162.1 ACK163.1 ACK172.1 ACK178.1 ACK180.1 ACK185.1 ACK188.1 ACK191.1 ACK197.1 ACK198.1 ACK202.1 ACK203.1 ACK210.1 ACK235.1 ACK236.1 ACK237.1 ACK239.1 ACK246.1 ACK254.1 ACK255.1 ACK262.1 ACK264.1 ACK265.1… Full codes in the FDA record | 41,745 devices (US-32,782, OUS-8,963) |
| Z-2507-2023 | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 3670 UDI-DI Codes: 05415067046383 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 AAP040.1 AAP044.1 AAP047.1 AAP049.1 AAP053.1 AAP054.1 AAP055.1 AAP056.1 AAP059.1 AAP060.1 AAP062.1 AAP069.1 AAP075.1 AAP079.1 AAP081.1 AAP082.1 AAP083.1 AAP089.1 AAP092.1 AAP093.1 AAP094.1 AAP099.1 AAP100.1 AAP106.1 AAP109.1 AAP113.1 AAP115.1 AAP117.1 AAP118.1 AAP119.1 AAP122.1 AAP124.1 AAP125.1 AAP129.1 AAP133.1 AAP134.1 AAP135.1 AAP139.1 AAP144.1 AAP146.1 AAP148.1 AAP157.1 AAP160.1 AAP162.1 AAP166.1 AAP167.1 AAP168.1 AAP173.1 AAP174.1 AAP176.1 AAP179.1 AAP182.1 AAP185.1 AAP190.1 AAP196.1 AAP199.1 AAP202.1 AAP203.1 AAP209.1 AAP211.1 AAP212.1 AAP213.1 AAP214.1 AAP216.1 AAP219.1 AAP221.1 AAP223.1 AAP225.1 AAP228.1 AAP229.1 AAP230.1 AAP233.1 AAP234.1 AAP242.1 AAP243.1 AAP252.1 AAP260.1 AAP261.1 AAP263.1 AAP264.1 AAP268.1 AAP270.1 AAP274.1 AAP275.1 AAP277.1 AAP278.1 AAP280.1 AAP281.1 AAP283.1 AAP285.1 AAP286.1 AAP288.1 AAP289.1 AAP290.1 AAP292.1 AAP294.1 AAP301.1 AAP302.1 AAP305.1 AAP308.1 AAP310.1 AAP311.1 AAP313.1 AAP315.1 AAP319.1 AAP321.1 AAP325.1 AAP326.1 AAP334.1 AAP336.1 AAP338.1 AAP342.1 AAP346.1 AAP351.1 AAP354.1 AAP358.1 AAP359.1 AAP365.1 AAP368.1 AAP372.1 AAP382.1 AAP386.1 AAP389.1 AAP390.1 AAP396.1 AAP411.1 AAT449.1 AAT450.1 AAT452.1 AAT453.1 AAT457.1 AAT460.1 AAT461.1 AAT463.1 AAT465.1 AAT470.1 AAT472.1 AAT473.1 AAT474.1 AAT477.1 AAT479.1 AAT482.1 AAT483.1 AAT484.1 AAT485.1 AAT486.1 AAT487.1 AAT490.1 AAT492.1 AAT504.1 AAT514.1 AAT522.1 AAT523.1 AAT532.1 AAT533.1 AAT538.1 AAT543.1 AAT547.1 AAT552.1 AAT553.1 AAT555.1 AAT559.1 AAT560.1 AAT561.1 AAT562.1 AAT564.1 AAT566.1 AAT568.1 AAT573.1 AAT584.1 AAT594.1 AAT597.1 AAT599.1 AAT608.1 AAT612.1 AAT614.1 AAT617.1 AAT619.1 AAT622.1 AAT624.1 AAT632.1 AAT633.1 AAT635.1 AAT636.1 AAT641.1 AAT642.1 AAT644.1 AAT647.1 AAT649.1 AAT650.1 AAT651.1 AAT653.1 AAT654.1 AAT656.1 AAT659.1 AAT662.1 AAT666.1 AAT669.1 AAT670.1 AAT671.1 AAT673.1 AAT676.1 AAT679.1 AAT680.1 AAT684.1 AAT689.1 AAT690.1 AAT693.1 AAT695.1 AAT697.1 AAT698.1 AAT699.1 AAT700.1 AAT701.1 AAT703.1 AAT705.1 AAT706.1 AAT709.1 AAT717.1 AAT719.1 AAT723.1 AAT728.1 AAT742.1 AAT745.1 AAT746.1 AAT747.1 AAT748.1 AAT753.1 AAT757.1 AAT758.1 AAT762.1 AAT763.1 AAT768.1 AAT770.1 AAT773.1 AAT775.1 AAT777.1 AAT780.1 AAT782.1 AAT784.1 AAT787.1 AAT799.1 AAT800.1 AAT802.1 AAT803.1 AAT806.1 AAT808.1 AAT809.1 AAT811.1 AAT813.1 AAT817.1 AAT822.1 AAT823.1 AAT827.1 AAT828.1 AAT833.1 AAT834.1 AAT837.1 AAT838.1 AAT839.1 AAT840.1 AAT847.1 AAT850.1 AAT851.1 AAT852.1 AAT853.1 AAT856.1 AAT857.1 AAT858.1 AAT859.1 AAT862.1 AAT863.1 AAT864.1 AAT868.1 AAT871.1 AAT875.1 AAT881.1 AAT884.1 AAT886.1 AAT887.1 AAT888.1 AAT892.1 AAT894.1 AAT895.1 AAT896.1 AAT898.1 AAT900.1 AAT901.1 AAT904.1 AAT905.1 AAT914.1 AAT915.1 AAT916.1 AAT917.1 AAT919.1 AAT921.1 AAT922.1 AAT924.1 AAT926.1 AAT930.1 AAT937.1 AAT938.1 AAT940.1 AAT944.1 AAT946.1 AAT947.1 AAT948.1 AAT950.1 AAT951.1 AAT959.1 AAT962.1 AAT969.1 AAT970.1 AAT978.1 AAT981.1 AAT998.1 AAU005.1 AAU007.1 AAU011.1 AAU012.1 AAU014.1 AAU017.1 AAU018.1 AAU019.1 AAU021.1 AAU026.1 AAU027.1 AAU030.1 AAU033.1 AAU035.1 AAU036.1 AAU038.1 AAU042.1 AAU045.1 AAU050.1 AAU053.1 AAU058.1 AAU060.1 AAU061.1 AAU062.1 AAU065.1 AAU066.1 AAU069.1 AAU072.1 AAU076.1 AAU081.1 AAU082.1 AAU083.1 AAU085.1 AAU088.1 AAU089.1 AAU092.1 AAU093.1 AAU099.1 AAU100.1 AAU101.1 AAU102.1 AAU104.1 AAU106.1 AAU109.1 AAU111.1 AAU118.1 AAU119.1 AAU120.1 AAU121.1 AAU123.1 AAU127.1 AAU132.1 AAU133.1 AAU134.1 AAU136.1 AAU137.1 AAU139.1 AAU140.1 AAU141.1 AAU145.1 AAU147.1 AAU149.1 AAU150.1 AAU152.1 AAU154.1 AAU157.1 AAU158.1 AAU159.1 AAU161.1 AAU164.1 AAU165.1 AAU166.1 AAU168.1 AAU169.1 AAU170.1 ABA930.1 ABA931.1 ABA932.1 ABA934.1 ABA938.1 ABA939.1 ABA941.1 ABA944.1 ABA947.1 ABA949.1 ABA951.1 ABA953.1 ABA954.1 ABA955.1 ABA956.1 ABA961.1 ABA967.1 ABA969.1 ABA973.1 ABA975.1 ABA977.1 ABA979.1 ABA981.1 ABA983.1 ABA986.1 ABA987.1 ABA992.1 ABA996.1 ABA997.1 ABA999.1 ABB006.1 ABB009.1 ABB014.1 ABB025.1 ABB026.1 ABB032.1 ABB033.1 ABB038.1 ABB039.1 ABB041.1 ABB044.1 ABB045.1 ABB047.1 ABB050.1 ABB054.1 ABB057.1 ABB058.1 ABB060.1 ABB061.1 ABB062.1 ABB063.1 ABB065.1 ABB066.1 ABB068.1 ABB069.1 ABB070.1 ABB071.1 ABB075.1 ABB078.1 ABB081.1 ABB083.1 ABB084.1 ABB086.1 ABB087.1 ABB089.1 ABB091.1 ABB092.1 ABB093.1 ABB096.1 ABB097.1 ABB098.1 ABB110.1 ABB113.1 ABB117.1 ABB118.1 ABB120.1 ABB123.1 ABB124.1 ABB125.1 ABB126.1 ABB127.1 ABB129.1 ABB130.1 ABB132.1 ABB135.1 ABB136.1 ABB137.1 ABB138.1 ABB142.1 ABB144.1 ABB146.1 ABB147.1 ABB149.1 ABB150.1 ABB152.1 ABB153.1 ABB154.1 ABB157.1 ABB158.1 ABB160.1 ABB161.1 ABB164.1 ABB168.1 ABB171.1 ABB172.1 ABB173.1 ABB176.1 ABB177.1 ABB178.1 ABB179.1 ABJ138.1 ABJ139.1 ABJ146.1 ABJ157.1 ABJ166.1 ABJ168.1 ABJ170.1 ABJ180.1 ABJ182.1 ABJ183.1 ABJ188.1 ABJ190.1 ABJ195.1 ABJ208.1 ABJ212.1 ABJ213.1 ABJ220.1 ABJ229.1 ABJ236.1 ABJ239.1 ABJ246.1 ABJ247.1 ABJ250.1 ABJ252.1 ABJ257.1 ABJ260.1 ABJ261.1 ABJ271.1 ABJ272.1 ABJ273.1 ABJ274.1 ABJ286.1 ABJ287.1 ABJ288.1 ABJ291.1 ABJ292.1 ABJ293.1 ABJ296.1 ABJ299.1 ABJ302.1 ABJ303.1 ABJ306.1 ABJ308.1 ABJ314.1 ABJ332.1 ABJ334.1 ABJ344.1 ABJ350.1 ABJ356.1 ABJ358.1 ABJ361.1 ABJ364.1 ABJ369.1 ABJ375.1 ABJ378.1 ABJ380.1 ABJ387.1 ABJ398.1 ABJ399.1 ABJ403.1 ABJ404.1 ABJ405.1 ABJ407.1 ABJ409.1 ABJ413.1 ABJ416.1 ABJ417.1 ABJ419.1 ABJ420.1 ABJ423.1 ABJ424.1 ABJ426.1 ABJ429.1 ABJ431.1 ABJ438.1 ABJ441.1 ABJ451.1 ABJ459.1 ABJ462.1 ABJ468.1 ABJ481.1 ABJ496.1 ABJ498.1 ABJ511.1 ABJ512.1 ABJ518.1 ABJ520.1 ABJ521.1 ABJ522.1 ABJ523.1 ABJ524.1 ABJ525.1 ABJ527.1 ABJ529.1 ABJ531.1 ABJ532.1 ABJ533.1 ABJ545.1 ABJ567.1 ABJ572.1 ABJ583.1 ABJ588.1 ABJ593.1 ABJ594.1 ABJ595.1 ABJ600.1 ABJ604.1 ABJ607.1 ABJ613.1 ABJ616.1 ABJ617.1 ABJ621.1 ABJ623.1 ABJ630.1 ABM165.1 ABM170.1 ABM174.1 ABM176.1 ABM177.1 ABM180.1 ABM190.1 ABM191.1 ABM193.1 ABM202.1 ABM203.1 ABM204.1 ABM206.1 ABM207.1 ABM208.1 ABM214.1 ABM216.1 ABM223.1 ABM224.1 ABM229.1 ABM230.1 ABM232.1 ABM233.1 ABM235.1 ABM238.1 ABM239.1 ABM240.1 ABM246.1 ABM250.1 ABM252.1 ABM253.1 ABM255.1 ABM258.1 ABM259.1 ABM262.1 ABM264.1 ABM266.1 ABM275.1 ABM276.1 ABM277.1 ABM279.1 ABM281.1 ABM283.1 ABM292.1 ABM294.1 ABM299.1 ABM300.1 ABM301.1 ABM304.1 ABM305.1 ABM318.1 ABM320.1 ABM321.1 ABM322.1 ABM325.1 ABM332.1 ABM333.1 ABM336.1 ABM340.1 ABM341.1 ABM342.1 ABM350.1 ABM354.1 ABM356.1 ABM365.1 ABM366.1 ABM367.1 ABM368.1 ABM369.1 ABM372.1 ABM374.1 ABM376.1 ABM377.1 ABM378.1 ABM379.1 ABM380.1 ABM383.1 ABM384.1 ABM390.1 ABM391.1 ABM393.1 ABM394.1 ABM398.1 ABM401.1 ABM402.1 ABM403.1 ABM405.1 ABM406.1 ABM417.1 ABM418.1 ABM421.1 ABM429.1 ABM433.1 ABM435.1 ABM436.1 ABM437.1 ABM440.1 ABM441.1 ABM449.1 ABM454.1 ABM456.1 ABM458.1 ABM470.1 ABM473.1 ABM479.1 ABM480.1 ABM483.1 ABM488.1 ABM495.1 ABM497.1 ABM499.1 ABM507.1 ABM509.1 ABM513.1 ABM514.1 ABM515.1 ABM516.1 ABM526.1 ABM529.1 ABM531.1 ABM534.1 ABM538.1 ABM543.1 ABM548.1 ABM550.1 ABM560.1 ABM562.1 ABM564.1 ABM567.1 ABM568.1 ABM571.1 ABM573.1 ABM582.1 ABM583.1 ABM586.1 ABM587.1 ABM590.1 ABM596.1 ABM598.1 ABM599.1 ABM610.1 ABM618.1 ABM623.1 ABM626.1 ABM628.1 ABM632.1 ABM634.1 ABM643.1 ABM645.1 ABM647.1 ABM648.1 ABM650.1 ABT691.1 ABT694.1 ABT696.1 ABT698.1 ABT699.1 ABT701.1 ABT718.1 ABT719.1 ABT723.1 ABT729.1 ABT731.1 ABT734.1 ABT741.1 ABT747.1 ABT755.1 ABT756.1 ABT758.1 ABT759.1 ABT764.1 ABT765.1 ABT766.1 ABT769.1 ABT772.1 ABT780.1 ABT781.1 ABT782.1 ABT783.1 ABT790.1 ABT792.1 ABT801.1 ABT813.1 ABT815.1 ABT819.1 ABT823.1 ABT826.1 ABT831.1 ABT833.1 ABT842.1 ABT845.1 ABT855.1 ABT856.1 ABT857.1 ABT858.1 ABT859.1 ABT864.1 ABT865.1 ABT868.1 ABT875.1 ABT876.1 ABT879.1 ABT886.1 ABT889.1 ABT890.1 ABT891.1 ABT895.1 ABT896.1 ABT901.1 ABT904.1 ABT905.1 ABT907.1 ABT909.1 ABT911.1 ABT912.1 ABT933.1 ABT936.1 ABT939.1 ABT941.1 ABT943.1 ABT949.1 ABT951.1 ABT957.1 ABT964.1 ABT966.1 ABT971.1 ABT972.1 ABT976.1 ABT978.1 ABT987.1 ABT993.1 ABT994.1 ABT995.1 ABT999.1 ABU009.1 ABU012.1 ABU016.1 ABU019.1 ABU025.1 ABU029.1 ABU032.1 ABU037.1 ABU038.1 ABU039.1 ABU041.1 ABU044.1 ABU046.1 ABU054.1 ABU055.1 ABU059.1 ABU067.1 ABU072.1 ABU074.1 ABU086.1 ABU087.1 ABU090.1 ABU091.1 ABU098.1 ABU109.1 ABU111.1 ABU112.1 ABU118.1 ABU122.1 ABU124.1 ABU125.1 ABU136.1 ABU137.1 ABU139.1 ABU140.1 ABU148.1 ABU151.1 ABU158.1 ABU159.1 ABU166.1 ABU167.1 ABU169.1 ABU171.1 ABU178.1 ABU180.1 ABU182.1 ACD618.1 ACD625.1 ACD633.1 ACD636.1 ACD637.1 ACD641.1 ACD646.1 ACD647.1 ACD651.1 ACD653.1 ACD658.1 ACD660.1 ACD661.1 ACD662.1 ACD672.1 ACD673.1 ACD679.1 ACD680.1 ACD688.1 ACD692.1 ACD700.1 ACD708.1 ACD717.1 ACD720.1 ACD723.1 ACD726.1 ACD727.1 ACD734.1 ACD735.1 ACD737.1 ACD738.1 ACD740.1 ACD742.1 ACD743.1 ACD744.1 ACD751.1 ACD753.1 ACD754.1 ACD755.1 ACD756.1 ACD759.1 ACD786.1 ACD787.1 ACD788.1 ACD804.1 ACD808.1 ACD816.1 ACD817.1 ACD824.1 ACD827.1 ACD831.1 ACD832.1 ACD837.1 ACD843.1 ACD847.1 ACE645.1 ACE659.1 ACE663.1 ACE668.1 ACE671.1 ACE672.1 ACE673.1 ACE678.1 ACE686.1 ACE687.1 ACE694.1 ACE701.1 ACE703.1 ACE704.1 ACE707.1 ACE710.1 ACE711.1 ACE712.1 ACE713.1 ACE715.1 ACE717.1 ACE718.1 ACE720.1 ACE724.1 ACE726.1 ACE728.1 ACE729.1 ACE730.1 ACE731.1 ACE733.1 ACE734.1 ACE736.1 ACE737.1 ACE746.1 ACE748.1 ACE754.1 ACE755.1 ACE761.1 ACE765.1 ACE773.1 ACE775.1 ACE781.1 ACE789.1 ACE793.1 ACE797.1 ACE798.1 ACE799.1 ACE802.1 ACE803.1 ACE804.1 ACE805.1 ACE810.1 ACE815.1 ACE816.1 ACE817.1 ACE818.1 ACE820.1 ACE825.1 ACE826.1 ACE830.1 ACE833.1 ACE841.1 ACE842.1 ACE844.1 ACE845.1 ACE847.1 ACE851.1 ACE853.1 ACE855.1 ACE859.1 ACE861.1 ACE866.1 ACE870.1 ACE872.1 ACE885.1 ACE886.1 ACE890.1 ACE891.1 ACE895.1 ACE902.1 ACE923.1 ACE924.1 ACE928.1 ACE932.1 ACE934.1 ACE941.1 ACE945.1 ACE946.1 ACE951.1 ACE952.1 ACE955.1 ACE957.1 ACE958.1 ACE963.1 ACE965.1 ACE966.1 ACE968.1 ACE972.1 ACE975.1 ACE976.1 ACE978.1 ACE985.1 ACE988.1 ACE989.1 ACE993.1 ACF012.1 ACF016.1 ACF020.1 ACF021.1 ACF029.1 ACF031.1 ACF033.1 ACF034.1 ACF036.1 ACF041.1 ACF050.1 ACF051.1 ACF052.1 ACF053.1 ACF059.1 ACF066.1 ACF069.1 ACF071.1 ACF077.1 ACF078.1 ACF079.1 ACF080.1 ACF081.1 ACF083.1 ACF086.1 ACF087.1 ACF089.1 ACF090.1 ACF093.1 ACK134.1 ACK137.1 ACK142.1 ACK156.1 ACK157.1 ACK162.1 ACK163.1 ACK172.1 ACK178.1 ACK180.1 ACK185.1 ACK188.1 ACK191.1 ACK197.1 ACK198.1 ACK202.1 ACK203.1 ACK210.1 ACK235.1 ACK236.1 ACK237.1 ACK239.1 ACK246.1 ACK254.1 ACK255.1 ACK262.1 ACK264.1 ACK265.1 ACK267.1 ACK271.1 ACK272.1 ACK274.1 ACK277.1 ACK279.1 ACK280.1… Full codes in the FDA record | 2,242 device (US only) |
| Z-2508-2023 | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 3672 UDI-DI Codes: 05415067046406 Serial Numbers: US CBW328.1 CCA167.1 CCA177.1 CCU613.1 CCV760.1 CCX700.1 CCY890.1 CDR307.1 CDW220.1 CEC548.1 CEC719.1 CEE095.1 CEH111.1 CEH156.1 CEH200.1 CEH272.1 CEH293.1 CEH334.1 CEH964.1 CEH975.1 CEH993.1 CEK127.1 CEK258.1 CEK265.1 CEK271.1 CEK310.1 CEK432.1 CEM232.1 CEM340.1 CEM349.1 CEM375.1 CEM383.1 CEM396.1 CEN429.1 CEN444.1 CEP494.1 CEP497.1 CEP537.1 CEP540.1 CEP541.1 CEP553.1 CEP554.1 CEP562.1 CEP585.1 CEP645.1 CEP658.1 CEP663.1 CEP671.1 CEP685.1 CEP725.1 CEP730.1 CEP838.1 CEP847.1 CEP867.1 CER393.1 CER395.1 CER462.1 CER482.1 CER509.1 CER576.1 CET134.1 CET147.1 CET298.1 CET336.1 CET343.1 CET649.1 CEY608.1 CEY648.1 CFL299.1 CFL403.1 CFL540.1 CFL582.1 CFP963.1 CFP987.1 CFP991.1 CFR079.1 CFR100.1 CFR121.1 CFR392.1 CFR446.1 CFR478.1 CFR585.1 CFU079.1 CFU082.1 CFU091.1 CFU097.1 CFU098.1 CFU099.1 CFU121.1 CFU126.1 CFU132.1 CFU145.1 CFU333.1 CFU401.1 CFU426.1 CFU441.1 CFU460.1 CFU467.1 CFU472.1 CFU483.1 CFU526.1 CFU547.1 CFU569.1 CFU646.1 CFU687.1 CFV457.1 CFV588.1 CFV718.1 CFX211.1 CGA013.1 CGA029.1 CGA065.1 CGA097.1 CGA145.1 CGA331.1 CGA365.1 CGA406.1 CGA426.1 CGA451.1 CGA491.1 CGA500.1 CGA515.1 CGA581.1 CGC898.1 CGC908.1 CGC916.1 CGC921.1 CGC926.1 CGC955.1 CGC957.1 CGD063.1 CGD070.1 CGD076.1 CGD085.1 CGD101.1 CGD111.1 CGD119.1 CGD123.1 CGD192.1 CGD193.1 CGD220.1 CGD231.1 CGD240.1 CGD248.1 CGD251.1 CGD277.1 CGD278.1 CGD283.1 CGD308.1 CGD342.1 CGD343.1 CGD362.1 CGD694.1 CGD719.1 CGD739.1 CGD777.1 CGD790.1 CGD832.1 CGD892.1 CGG890.1 CGH131.1 CGH175.1 CGH183.1 CGH199.1 CGH245.1 CGH346.1 CGH413.1 CGL108.1 CGL207.1 CGL321.1 CGL863.1 CGL866.1 CGL889.1 CGP051.1 CGP078.1 CGP326.1 CGP615.1 CGS914.1 CGW231.1 CHB011.1 CHE598.1 CHE845.1 CHF161.1 CHF178.1 CHH717.1 CHH744.1 CHH773.1 CHJ032.1 CHK331.1 CHK354.1 CHK434.1 CHK648.1 CHM211.1 CHM389.1 CHM509.1 CHP603.1 CHP605.1 CHP621.1 CHR155.1 CHR240.1 CHT217.1 CHT238.1 CHT240.1 CHT241.1 CHT243.1 CHT245.1 CHT272.1 CHT356.1 CHT361.1 CHT373.1 CHT469.1 CHT478.1 CHT539.1 CHT553.1 CHT561.1 CHT589.1 CHT609.1 CHT624.1 CHT758.1 CHT815.1 CHT834.1 CHV674.1 CHV680.1 CHV710.1 CHV713.1 CHV794.1 CHV901.1 CHV989.1 CHW217.1 CHW262.1 CHW263.1 CHW306.1 CHW350.1 CHW362.1 CHW526.1 CHW560.1 CHW590.1 CHW591.1 CHW640.1 CHZ471.1 CHZ563.1 CHZ576.1 CJA246.1 CJG129.1 CJG177.1 CJM932.1 CJM940.1 CJN773.1 CJN780.1 CJN879.1 CJN987.1 CJP047.1 CJW418.1 CJW475.1 CJW534.1 CJW548.1 CJW586.1 CJX925.1 CJX962.1 CJX982.1 CJX986.1 CJY012.1 CJY075.1 CJY111.1 CJY226.1 CJY238.1 CJY304.1 CJY323.1 CJY360.1 CJY409.1 CJZ061.1 CJZ103.1 CJZ135.1 CJZ157.1 CJZ224.1 CJZ241.1 CJZ253.1 CJZ256.1 CJZ283.1 CJZ293.1 CJZ300.1 CJZ330.1 CJZ420.1 CJZ444.1 CJZ450.1 CKB402.1 CKB428.1 CKB439.1 CKB447.1 CKB487.1 CKB507.1 CKB608.1 CKB624.1 CKB654.1 CKB696.1 CKB725.1 CKB767.1 CKB887.1 CKD072.1 CKF569.1 CKF587.1 CKG394.1 CKG550.1 CKG586.1 CKG607.1 CKG915.1 CKG954.1 CKG956.1 CKG962.1 CKH467.1 CKH606.1 CKH692.1 CKH719.1 CKH736.1 CKH765.1 CKH774.1 CKH786.1 CKH815.1 CKH859.1 CKH923.1 CKL195.1 CKL217.1 CKL236.1 CKL295.1 CKL345.1 CKL464.1 CKL487.1 CKP251.1 CKP255.1 CKP277.1 CKP291.1 CKP393.1 CKP435.1 CKP483.1 CKP495.1 CKP563.1 CKP656.1 CKP678.1 CKP682.1 CKP717.1 CKP733.1 CKP803.1 CKP939.1 CKS483.1 CKS519.1 CKS531.1 CKS552.1 CKS588.1 CKS590.1 CKS616.1 CKS641.1 CKS662.1 CKS673.1 CKS684.1 CKS692.1 CKS698.1 CKS706.1 CKS827.1 CKS856.1 CKS869.1 CKS954.1 CKS986.1 CKS992.1 CKS994.1 CKS997.1 CKT159.1 CKY723.1 CKY781.1 CLC604.1 CLD150.1 CLD293.1 CLF739.1 CLF855.1 CLF880.1 CLF888.1 CLF901.1 CLG005.1 CLG094.1 CLG124.1 CLG391.1 CLG393.1 CLG395.1 CLG396.1 CLG423.1 CLG457.1 CLG534.1 CLK164.1 | 387 devices (US only) |
| Z-2509-2023 | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 3664 UDI-DI Codes: 05415067020215 Serial Numbers: US AAP267.1 AAP380.1 ADJ914.1 ADN375.1 ADR612.1 ADR812.1 ADR986.1 ADS012.1 ADW504.1 ADW635.1 ADW707.1 ADW724.1 AEJ059.1 AEM902.1 AFB279.1 AFB934.1 AFG268.1 AFG350.1 AFG397.1 AFG464.1 AFG805.1 AFH541.1 AFH553.1 AFH568.1 AFH575.1 AFH576.1 AFH604.1 AFH613.1 AFH617.1 AFH639.1 AFH674.1 AFH677.1 AFH682.1 AFH703.1 AFZ616.1 AFZ687.1 AGA013.1 AGA017.1 AGA052.1 AGA096.1 AGM898.1 AGN323.1 AGU357.1 AHD751.1 AHD757.1 AHD776.1 AHK508.1 AHK532.1 AHK534.1 AHK572.1 AHK587.1 AHK590.1 AHK635.1 AHK638.1 AHK737.1 AHK983.1 AHK988.1 AHL190.1 AHV733.1 AHV737.1 AHV741.1 AHV948.1 AHW119.1 AHW230.1 AHW240.1 AHW254.1 AHW281.1 AHW322.1 AHW358.1 AHW386.1 AHW389.1 AHW399.1 AHW459.1 AHW487.1 AHW515.1 AHW533.1 AHW583.1 AHW624.1 AHW639.1 AHW652.1 AHW733.1 AJW507.1 AJW539.1 AJW598.1 AKB517.1 AKB528.1 AKB571.1 AKB573.1 AKB620.1 AKB627.1 AKB666.1 AKB734.1 AKB780.1 AKB856.1 AKB864.1 AKB876.1 AKB881.1 AKB951.1 AKB959.1 AKB962.1 AKB974.1 AKB975.1 AKB994.1 AKC002.1 AKC012.1 AKC028.1 AKC042.1 AKC049.1 AKC060.1 AKC064.1 AKC076.1 AKC111.1 AKC112.1 AKC123.1 AKC126.1 AKC136.1 AKC163.1 AKU509.1 AKU514.1 AKU522.1 AKU524.1 AKU527.1 AKU530.1 AKU538.1 AKU577.1 AKU593.1 AKU606.1 AKU625.1 AKU656.1 AKU668.1 AKU686.1 AKU693.1 AKU695.1 AKU713.1 AKU714.1 AKU716.1 AKU725.1 AKU731.1 AKU734.1 AKU737.1 AKU739.1 AKU760.1 AKU772.1 AKU798.1 AKU801.1 AKU806.1 AKU814.1 AKU836.1 AKU851.1 AKU862.1 AKU887.1 AKU890.1 AKU897.1 AKU911.1 AKU914.1 AKU920.1 AKU925.1 AKU931.1 AKU937.1 AKU947.1 AKU967.1 AKU971.1 AKU987.1 AKV004.1 AKV012.1 AKV016.1 AKV047.1 AKV050.1 AKV089.1 AKV090.1 AKV094.1 AKV096.1 AKV100.1 AKV114.1 AKV131.1 AKV137.1 AKV144.1 AKV147.1 AKV148.1 AKV157.1 AKV163.1 AKV168.1 AKV169.1 AKV173.1 AKV177.1 AKV188.1 AKV189.1 AKV199.1 AKV220.1 AKV228.1 AKV233.1 AKV242.1 AKV261.1 AKV265.1 AKV267.1 AKV270.1 AKV271.1 AKV274.1 AKV276.1 AKV277.1 AKV281.1 AKV284.1 AKV286.1 AKV292.1 AKV299.1 AKV300.1 AKV307.1 AKV318.1 AKV324.1 AKV335.1 AKV337.1 AKV350.1 AKV355.1 AKV358.1 AKV361.1 AKV363.1 AKV370.1 AKV377.1 AKV386.1 AKV387.1 AKV391.1 AKV394.1 AKV396.1 AKV397.1 AKV401.1 AKV407.1 AKV421.1 AKV440.1 AKV445.1 AKV458.1 AKV464.1 AKV466.1 AKV467.1 AKV475.1 AKV489.1 AKV492.1 AKV611.1 ALE766.1 ALE773.1 ALE983.1 ALE988.1 ALF014.1 ALF111.1 ALJ331.1 ALJ413.1 ALJ429.1 ALJ824.1 ALK038.1 ALK051.1 ALK054.1 ALK061.1 ALY991.1 ALZ222.1 ALZ268.1 ALZ413.1 ALZ427.1 AMR939.1 AMS269.1 AMS329.1 AMS334.1 AMS338.1 AMS340.1 AMS370.1 AMS440.1 AMS778.1 AMT011.1 AMT086.1 AMT111.1 AMT121.1 AMT195.1 ANG972.1 ANG988.1 ANH042.1 ANH111.1 ANH152.1 ANH196.1 ANH226.1 ANH235.1 ANH264.1 ANH268.1 ANH283.1 ANH286.1 ANH291.1 ANH394.1 ANH423.1 ANH437.1 ANH441.1 ANH447.1 ANH458.1 ANH482.1 ANH535.1 ANH565.1 ANH588.1 ANH609.1 ANH640.1 ANL380.1 ANL385.1 ANL388.1 ANL389.1 ANL397.1 ANL399.1 ANL402.1 ANL403.1 ANL418.1 ANL420.1 ANL424.1 ANL425.1 ANL430.1 ANL431.1 ANL435.1 ANL474.1 ANL482.1 ANL491.1 ANL493.1 ANL497.1 ANL498.1 ANL500.1 ANL501.1 ANL502.1 ANL506.1 ANL517.1 ANL726.1 ANL734.1 ANL781.1 ANM069.1 ANT277.1 ANT283.1 ANT287.1 ANT296.1 ANT298.1 ANT307.1 ANT385.1 ANT404.1 ANT441.1 ANT472.1 ANT477.1 ANT534.1 ANT557.1 ANT618.1 ANT637.1 ANT730.1 ANT754.1 ANT867.1 ANT908.1 ANT911.1 ANU015.1 ANU020.1 ANU033.1 ANU075.1 ANU077.1 ANU088.1 ANU141.1 ANU172.1 ANU214.1 ANU217.1 ANU244.1 ANU271.1 ANU298.1 ANU300.1 ANU321.1 ANU333.1 ANU387.1 ANU398.1 ANU401.1 APA828.1 APA829.1 APA833.1 APA843.1 APA852.1 APA872.1 APA874.1 APA876.1 APA879.1 APA888.1 APA905.1 APA910.1 APA915.1 APA922.1 APA927.1 APA949.1 APA966.1 APA994.1 APB004.1 APB031.1 APB038.1 APB040.1 APB056.1 APB068.1 APB070.1 APB071.1 APB080.1 APB081.1 APB088.1 APB096.1 APB109.1 APB111.1 APB117.1 APB146.1 APB153.1 APB164.1 APB208.1 APB210.1 APB219.1 APB227.1 APB230.1 APB233.1 APB240.1 APB242.1 APB260.1 APB276.1 APB297.1 APB323.1 APB324.1 APB335.1 APB350.1 APB355.1 APB359.1 APB364.1 APB383.1 APB390.1 APB392.1 APB394.1 APB398.1 APB403.1 APB406.1 APB415.1 APB446.1 APB476.1 APB482.1 APB499.1 APB518.1 APB525.1 APB528.1 APB540.1 APB541.1 APB542.1 APB546.1 APB548.1 APB570.1 APB595.1 APB603.1 APB607.1 APB608.1 APB611.1 APB618.1 APB665.1 APB677.1 APB695.1 APB709.1 APB713.1 APB726.1 APB731.1 APB735.1 APB751.1 APB753.1 APB764.1 APB766.1 APB768.1 APB801.1 APB802.1 APB812.1 APB813.1 APB817.1 APB844.1 APB852.1 APB862.1 APB873.1 APB877.1 APB893.1 APB894.1 APB929.1 APB931.1 APB934.1 APB939.1 APC010.1 APC017.1 APC028.1 APC032.1 APC037.1 APC058.1 APC060.1 APC061.1 APC068.1 APC071.1 APC075.1 APC110.1 APE452.1 APE457.1 APE498.1 APE504.1 APE509.1 APE517.1 APE547.1 APE567.1 APE577.1 APE583.1 APE584.1 APE590.1 APE591.1 APE642.1 APE650.1 APE663.1 APE708.1 APE714.1 APE727.1 APE732.1 APE734.1 APE738.1 APE740.1 APE742.1 APE781.1 APE805.1 APE894.1 APE899.1 APE960.1 APE961.1 APE983.1 APE991.1 APF002.1 APF005.1 APF007.1 APF011.1 APF082.1 APF114.1 APF160.1 APK900.1 APK901.1 APK924.1 APK928.1 APK955.1 APK956.1 APK963.1 APK978.1 APK979.1 APK990.1 APK996.1 APL035.1 APL039.1 APL045.1 APL047.1 APL059.1 APL072.1 APL103.1 APL114.1 APL146.1 APL154.1 APL159.1 APL177.1 APL210.1 APL216.1 APL246.1 APL248.1 APL254.1 APL261.1 APL262.1 APL275.1 APL279.1 APL289.1 APL291.1 APL298.1 APL303.1 APL305.1 APL334.1 APL344.1 APL348.1 APL350.1 APL367.1 APL373.1 APL383.1 APL384.1 APL389.1 APL413.1 APL423.1 APL424.1 APL428.1 APL444.1 APL450.1 APL451.1 APL452.1 APL453.1 APL462.1 APL486.1 APL491.1 APL492.1 APL496.1 APL512.1 APL529.1 APL547.1 APL549.1 APL565.1 APL575.1 APL590.1 APL601.1 APL602.1 APL621.1 APL622.1 APS036.1 APS039.1 APS053.1 APS068.1 APS070.1 APS071.1 APS084.1 APS095.1 APS102.1 APS104.1 APS119.1 APS125.1 APS126.1 APS140.1 APS148.1 APS151.1 APS154.1 APS202.1 APS236.1 APS237.1 APS238.1 APS260.1 APS262.1 APS266.1 APS278.1 APS281.1 APS313.1 APS314.1 APS327.1 APS363.1 APS373.1 APS375.1 APS400.1 APS424.1 APS426.1 APS427.1 APS432.1 APS436.1 APZ173.1 APZ319.1 APZ392.1 APZ485.1 APZ509.1 APZ558.1 APZ593.1 APZ610.1 APZ620.1 APZ626.1 APZ641.1 APZ646.1 APZ648.1 APZ682.1 APZ697.1 APZ710.1 APZ713.1 APZ721.1 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AUM111.1 AUM117.1 AUM119.1 AUM144.1 AUM147.1 AUM149.1 AUM156.1 AUM373.1 AUM377.1 AUM381.1 AUM386.1 AUM395.1 AUM398.1 AUM402.1… Full codes in the FDA record | 17,394 devices (US-12,134; OUS-5,260) |
| Z-2510-2023 | Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 6660 UDI-DI Codes: 05415067030016 Serial Numbers: US AAD255.1 AAN997.1 AAP328.1 AAT540.1 AAT579.1 AAT652.1 AAT772.1 AAT783.1 AAT795.1 AAT797.1 AAT845.1 AAT902.1 AAT989.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABM541.1 ABM592.1 ABM630.1 ABT798.1 ABT829.1 ABT841.1 ABT900.1 ACD800.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE936.1 ACE939.1 ACE994.1 ACF048.1 ACK145.1 ACK161.1 ACK241.1 ACK511.1 ACK514.1 ACK549.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP686.1 ACP700.1 ACP712.1 ACP770.1 ACP780.1 ACP835.1 ACP869.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACT738.1 ACU349.1 ACU381.1 ACU424.1 ADR673.1 ADR679.1 ADR685.1 ADR787.1 ADR794.1 ADR852.1 ADR856.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH877.1 AEH883.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 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AYD274.1 AYD290.1 AYD339.1 AYD362.1 AYD397.1 AYD454.1 AYD460.1 AYD496.1 AYD506.1 AYD559.1 AYD607.1 AYD625.1 AYD632.1 AYD644.1… Full codes in the FDA record | 5,932 devices (US-4,464; OUS-1,468) |
| Z-2511-2023 | Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).; Model Number: 6662 UDI-DI Codes: 05415067030023 Serial Numbers: US AAD298.1 AAP149.1 AAP193.1 AAU029.1 ABA964.1 ABM581.1 ABM600.1 ABT745.1 ABT832.1 ABT883.1 ACD617.1 ACD686.1 ACD772.1 ACD773.1 ACD797.1 ACE661.1 ACK379.1 ACK583.1 ACK784.1 ACK837.1 ACP794.1 ACT645.1 ACT654.1 ACT684.1 ACT737.1 ACT796.1 ACT895.1 ACU006.1 ACU060.1 ACU081.1 ACU085.1 ACU091.1 ACU165.1 ACU220.1 ACU247.1 ADD484.1 ADD593.1 ADD635.1 ADD647.1 ADD673.1 ADD681.1 ADD754.1 ADD785.1 ADD792.1 ADD904.1 ADD905.1 ADD910.1 ADD946.1 ADD947.1 ADD970.1 ADD995.1 ADE002.1 ADE014.1 ADE027.1 ADE030.1 ADE032.1 ADE073.1 ADE100.1 ADE105.1 ADE129.1 ADE144.1 ADE152.1 ADJ719.1 ADK216.1 ADK277.1 ADN241.1 ADR337.1 ADR349.1 ADR353.1 ADR399.1 ADR432.1 ADR435.1 ADR452.1 ADR467.1 ADR522.1 ADR545.1 ADR604.1 ADR636.1 ADR662.1 ADR680.1 ADR682.1 ADR705.1 ADR813.1 ADR815.1 ADR829.1 ADR841.1 ADR924.1 ADR945.1 ADR951.1 ADR984.1 ADR985.1 ADW488.1 ADW495.1 ADW497.1 ADW520.1 ADW561.1 ADW566.1 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AUM624.1 AUM627.1 AUM628.1 AUM688.1 AUM690.1 AUM693.1 AUM703.1 AUM704.1 AUM711.1 AUM745.1 AUM763.1 AUM771.1 AUM795.1 AUM826.1 AUP013.1 AUP030.1 AUP133.1 AUP152.1 AUP161.1 AUP176.1 AUP183.1 AUP369.1 AUP488.1 AUP889.1 AUR428.1 AUR451.1 AUR632.1 AUR634.1 AUV777.1 AUV844.1 AUW691.1 AUW723.1 AUX252.1 AUX352.1 AUX434.1 AUX526.1 AVA226.1 AVA420.1 AVA502.1 AVA693.1 AVA715.1 AVA899.1 AVA920.1 AVB075.1 AVB126.1 AVD355.1 AVD403.1 AVD489.1 AVD768.1 AVD771.1 AVD788.1 AVD851.1 AVD862.1 AVE350.1 AVE395.1 AVE416.1 AVE437.1 AVE476.1 AVE504.1 AVE544.1 AVE545.1 AVE620.1 AVE657.1 AVE708.1 AVE781.1 AVF256.1 AVF274.1 AVF306.1 AVF357.1 AVF371.1 AVF428.1 AVF457.1 AVF512.1 AVF534.1 AVF554.1 AVF561.1 AVF571.1 AVF572.1 AVF687.1 AVF748.1 AVF817.1 AVF842.1 AVF856.1 AVK723.1 AVK740.1 AVK742.1 AVK754.1 AVK765.1 AVK779.1 AVK797.1 AVK872.1 AVK910.1 AVK940.1 AVK950.1 AVL007.1 AVL074.1 AVL104.1 AVL208.1 AVL935.1 AVL955.1 AVL958.1 AVL968.1 AVM153.1 AVM167.1 AVM192.1 AVM229.1 AVM237.1 AVM245.1 AVM249.1 AVM300.1 AVM324.1 AVN611.1 AVN622.1 AVN635.1 AVN669.1 AVN676.1 AVN708.1 AVN773.1 AVN812.1 AVN819.1 AVN828.1 AVN926.1 AVN970.1 AVN980.1 AVN991.1 AVP020.1 AVP026.1 AVP046.1 AVP050.1 AVP057.1 AVP061.1 AVP078.1 AVP137.1 AVP175.1 AVP191.1 AVP316.1 AVP372.1 AVP395.1 AVP718.1 AVP753.1 AVP772.1 AVP774.1 AVP781.1 AVP817.1 AVP841.1 AVP851.1 AVP859.1 AVP896.1 AVP899.1 AVP903.1 AVP910.1 AVP927.1 AVP946.1 AVP977.1 AVR004.1 AVR020.1 AVR022.1 AVR054.1 AVR068.1 AVR106.1 AVR202.1 AVR239.1 AVR264.1 AVR298.1 AVR390.1 AVR454.1 AVR477.1 AVR485.1 AVR545.1 AVR580.1 AVR717.1 AVR728.1 AVR731.1 AVR741.1 AVR752.1 AVR768.1 AVR807.1 AVW846.1 AVW893.1 AVW931.1 AVW986.1 AVX003.1 AVX017.1 AVX084.1 AVX088.1 AVX116.1 AVX169.1 AVX179.1 AVX187.1 AVX239.1 AVX285.1 AVX316.1 AVX362.1 AVX384.1 AVX390.1 AVX406.1 AVX407.1 AVX422.1 AVX486.1 AVX521.1 AVX531.1 AVX557.1 AVX601.1 AVY619.1 AVY633.1 AVY658.1 AVY675.1 AVY718.1 AVY742.1 AVY775.1 AVY827.1 AVY848.1 AVY849.1 AVY906.1 AVY950.1 AVZ036.1 AVZ041.1 AVZ043.1 AVZ084.1 AWB409.1 AWB420.1 AWB539.1 AWB612.1 AWB649.1 AWB704.1 AWB837.1 AWB878.1 AWB940.1 AWB945.1 AWB996.1 AWC033.1 AWC205.1 AWC254.1 AWC280.1 AWC410.1 AWC413.1 AWC491.1 AWC496.1 AWC661.1 AWC684.1 AWC694.1 AWC828.1 AWC837.1 AWC943.1 AWC977.1 AWD015.1 AWD125.1 AWD136.1 AWF809.1 AWH574.1 AWH763.1 AWH788.1 AWH798.1 AWH803.1 AWH853.1 AWH909.1 AWH933.1 AWH993.1 AWJ101.1 AWJ123.1 AWJ143.1 AWJ170.1 AWJ185.1 AWJ216.1 AWJ244.1 AWJ297.1 AWJ314.1 AWJ321.1 AWJ332.1 AWJ383.1 AWJ423.1 AWJ428.1 AWJ455.1 AWJ532.1 AWL473.1 AWL518.1 AWL525.1 AWL539.1 AWL564.1 AWL572.1 AWL584.1 AWL606.1 AWL609.1 AWL610.1 AWL614.1 AWL618.1 AWL633.1 AWP517.1 AWP595.1 AWP624.1 AWP741.1 AWP816.1 AWP830.1 AWP846.1 AWP865.1 AWP869.1 AWP874.1 AWP876.1 AWP885.1 AWP886.1 AWP899.1 AWP902.1 AWP989.1 AWP990.1 AWR019.1 AWR079.1 AWR118.1 AWR192.1 AWR309.1 AWR378.1 AWR427.1 AWR577.1 AWR686.1 AWT998.1 AWU136.1 AWW898.1 AWW912.1 AWW920.1 AWW950.1 AWW994.1 AWX070.1 AWX072.1 AWX073.1 AWX080.1 AWX159.1 AWX184.1 AWX220.1 AWX251.1 AWX252.1 AWX268.1 AWX274.1 AWX285.1 AWX293.1 AWX329.1 AWX378.1 AWX380.1 AWX385.1 AWX388.1 AWX417.1 AWX475.1 AWX517.1 AWX518.1 AWX552.1 AWX578.1 AWX582.1 AWX611.1 AWX619.1 AWX633.1 AWX645.1 AWX652.1 AWX653.1 AWX713.1 AWX736.1 AWX745.1 AWX756.1 AWX764.1 AWX767.1 AWX780.1 AWX781.1 AWX783.1 AWX797.1 AWX840.1 AWX877.1 AWX892.1 AWX915.1 AWX990.1 AWY002.1 AWY023.1 AWY049.1 AWY060.1 AWY068.1 AWY076.1 AWY082.1 AWY089.1 AWY104.1 AWY107.1 AWY143.1 AWY164.1 AWY192.1 AWY200.1 AWY210.1 AWY213.1 AWY284.1 AWY290.1 AWY308.1 AWY309.1 AWY339.1 AWY348.1 AWY379.1 AWY392.1 AWY408.1 AWY420.1 AXC787.1 AXE620.1 AXE632.1 AXE659.1 AXE685.1 AXE694.1 AXE698.1 AXE699.1 AXE766.1 AXE791.1 AXE809.1 AXE823.1 AXE831.1 AXE854.1 AXE880.1 AXE882.1 AXE889.1 AXE912.1 AXE973.1 AXE979.1 AXE986.1 AXF008.1 AXF012.1 AXF076.1 AXF090.1 AXF094.1 AXF110.1 AXF154.1 AXF166.1 AXF186.1 AXF213.1 AXF222.1 AXF224.1 AXF240.1 AXF245.1 AXF246.1 AXF247.1 AXF253.1 AXF265.1 AXF268.1 AXF307.1 AXF369.1 AXF375.1 AXF497.1 AXF506.1 AXF519.1 AXF541.1 AXF595.1 AXF600.1 AXF654.1 AXF769.1 AXF778.1 AXF798.1 AXJ818.1 AXK109.1 AXK133.1 AXK174.1 AXK197.1 AXK202.1 AXK204.1 AXK257.1 AXK264.1 AXK265.1 AXK266.1 AXK276.1 AXK287.1… Full codes in the FDA record | 16,395 devices (US-7,793; OUS-8,602) |
What to do — step by step
Check Device Details
Verify your device's model number is 3670 and serial numbers match the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2507-2023 (July 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2507-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.