Use caution Medical device recall · FDA · Published June 2, 2017
St. Jude Medical Infinity 7 IPG Recall: Risk of Lost Neuromodulation Therapy
St. Jude Medical recalls Infinity 7 implantable pulse generators (REF 6663) due to potential loss of neuromodulation therapy when exposed to monopolar electrosurgical devices during medical procedures.
Use caution until it’s fixed
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Contact the company
Recalling firmSt. Jude Medical, Inc.6901 Preston Rd · Plano, TX 75024-2508
What happened, in plain English
St. Jude Medical is recalling Infinity 7 implantable pulse generators (REF 6663) because they can lose neuromodulation therapy if exposed to certain medical devices during procedures. This recall affects patients receiving spinal cord stimulation treatments. Read more at govinfonow.com/recall/73967-st-jude-medical-infinity-7-ipg-recall-risk-of-lost.
Source Summary by GovInfoNow · govinfonow.com/recall/73967-st-jude-medical-infinity-7-ipg-recall-risk-of-lost · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2696-2017
Cite this page
“St. Jude Medical Infinity 7 IPG Recall: Risk of Lost Neuromodulation Therapy.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73967-st-jude-medical-infinity-7-ipg-recall-risk-of-lost. Based on FDA recall #Z-2696-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2696-2017%22&limit=1).
Why it’s dangerous
The Infinity IPG is conductive on all sides, which means it can act as an anode when exposed to monopolar electrosurgical devices during medical procedures. This exposure can cause the device to lose its neuromodulation therapy function, potentially requiring reprogramming or replacement.
Who’s affected
Patients with Infinity 7 implantable pulse generators (REF 6663) who receive spinal cord stimulation therapy are most at risk. This recall applies to individuals with the device implanted for neuromodulation treatment.
How to tell if you have this one
The recalled product is the Infinity 7 implantable pulse generator with reference number 6663. It is a medical device used for spinal cord stimulation therapy that requires a prescription (Rx only).
- Brand
St. Jude Medical- Category
Medical device
All 6 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 II- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2691-2017 | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim 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 IPGs are available in small and large sizes to accommodate different power needs.; AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD188.1 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 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 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 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AFZ824.1 AFZ825.1 AFZ826.1 AFZ830.1 AFZ834.1 AFZ837.1 AFZ841.1 AFZ843.1 AFZ845.1 AFZ846.1 AFZ853.1 AFZ855.1 AFZ856.1 AFZ857.1 AFZ865.1 AFZ866.1 AFZ869.1 AFZ871.1 AFZ873.1 AFZ874.1 AFZ878.1 AFZ888.1 AFZ894.1 AFZ895.1 AFZ900.1 AFZ902.1 AFZ905.1 AFZ909.1 AFZ917.1 AFZ922.1 AFZ924.1 AFZ928.1 AFZ942.1 AFZ955.1 AFZ956.1 AFZ958.1 AFZ959.1 AFZ961.1 AFZ964.1 AFZ976.1 AFZ985.1 AFZ986.1 AFZ987.1 AFZ990.1 AFZ997.1 AGA011.1 AGA025.1 AGA033.1 AGA037.1 AGA038.1 AGA041.1 AGA042.1 AGA046.1 AGA054.1 AGA058.1 AGA062.1 AGA065.1 AGA070.1 AGA073.1 AGA077.1 AGA080.1 AGA081.1 AGA082.1 AGA093.1 AGA097.1 AGA099.1 AGA100.1 AGA101.1 AGM575.1 AGM576.1 AGM577.1 AGM579.1 AGM581.1 AGM582.1 AGM597.1 AGM605.1 AGM609.1 AGM615.1 AGM621.1 AGM622.1 AGM626.1 AGM630.1 AGM635.1 AGM636.1 AGM639.1 AGM640.1 AGM641.1 AGM648.1 AGM649.1 AGM650.1 AGM651.1 AGM652.1 AGM653.1 AGM654.1 AGM661.1 AGM662.1 AGM664.1 AGM666.1 AGM676.1 AGM677.1 AGM680.1 AGM683.1 AGM687.1 AGM688.1 AGM689.1 AGM690.1 AGM692.1 AGM693.1 AGM694.1 AGM696.1 AGM697.1 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AGN372.1 AGN373.1 AGN379.1 AGN380.1 AGN382.1 AGN386.1 AGN388.1 AGN392.1 AGN398.1 AGN401.1 AGN402.1 AGN403.1 AGN405.1 AGN407.1 AGN408.1 AGN411.1 AGN412.1 AGN413.1 AGN414.1 AGN415.1 AGN417.1 AGN422.1 AGN424.1 AGN427.1 AGN428.1 AGN431.1 AGN432.1 AGN439.1 AGN441.1 AGN442.1 AGN443.1 AGN444.1 AGN445.1 AGN446.1 AGN451.1 AGN453.1 AGN455.1 AGN457.1 AGN458.1 AGN464.1 AGN471.1 AGN472.1 AGN475.1 AGN481.1 AGN482.1 AGN483.1 AGN484.1 AGN486.1 AGN487.1 AGN488.1 AGN489.1 AGN491.1 AGN492.1 AGN496.1 AGN497.1 AGN498.1 AGN499.1 AGN501.1 AGN505.1 | 8780 units |
| Z-2692-2017 | Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim 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 IPGs are available in small and large sizes to accommodate different power needs.; AAD135.1 AAD136.1 AAD137.1 AAD138.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 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 AAN923.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN947.1 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 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AFB544.1 AFB545.1 AFB546.1 AFB547.1 AFB549.1 AFB550.1 AFB551.1 AFB552.1 AFB553.1 AFB554.1 AFB555.1 AFB557.1 AFB558.1 AFB560.1 AFB562.1 AFB564.1 AFB565.1 AFB566.1 AFB567.1 AFB568.1 AFB569.1 AFB570.1 AFB571.1 AFB575.1 AFB576.1 AFB577.1 AFB578.1 AFB582.1 AFB583.1 AFB585.1 AFB586.1 AFB587.1 AFB588.1 AFB589.1 AFB590.1 AFB591.1 AFB592.1 AFB593.1 AFB594.1 AFB595.1 AFB596.1 AFB597.1 AFB598.1 AFB600.1 AFB603.1 AFB604.1 AFB605.1 AFB606.1 AFB607.1 AFB609.1 AFB610.1 AFB613.1 AFB615.1 AFB616.1 AFB617.1 AFB618.1 AFB619.1 AFB620.1 AFB621.1 AFB623.1 AFB625.1 AFB630.1 AFB632.1 AFB634.1 AFB636.1 AFB637.1 AFB638.1 AFB639.1 AFB640.1 AFB642.1 AFB644.1 AFB645.1 AFB646.1 AFB650.1 AFB652.1 AFB653.1 AFB654.1 AFB656.1 AFB660.1 AFB661.1 AFB662.1 AFB665.1 AFB666.1 AFB668.1 AFB678.1 AFB681.1 AFB683.1 AFB686.1 AFB688.1 AFB689.1 AFB690.1 AFB693.1 AFB694.1 AFB695.1 AFB696.1 AFB697.1 AFB698.1 AFB701.1 AFB704.1 AFB705.1 AFB706.1 AFB708.1 AFB711.1 AFB712.1 AFB713.1 AFB715.1 AFB719.1 AFB720.1 AFB721.1 AFB722.1 AFB724.1 AFB728.1 AFB729.1 AFB733.1 AFB734.1 AFB735.1 AFB736.1 AFB737.1 AFB738.1 AFB739.1 AFB741.1 AFB743.1 AFB744.1 AFB745.1 AFB747.1 AFB748.1 AFB749.1 AFB751.1 AFB752.1 AFB753.1 AFB754.1 AFB755.1 AFB756.1 AFB757.1 AFB759.1 AFB760.1 AFB761.1 AFB762.1 AFB763.1 AFB764.1 AFB765.1 AFB767.1 AFB768.1 AFB770.1 AFB771.1 AFB772.1 AFB774.1 AFB776.1 AFB777.1 AFB778.1 AFB779.1 AFB780.1 AFB783.1 AFB784.1 AFB787.1 AFB790.1 AFB791.1 AFB792.1 AFB794.1 AFB795.1 AFB796.1 AFB798.1 AFB801.1 AFB802.1 AFB803.1 AFB805.1 AFB806.1 AFB807.1 AFB808.1 AFB810.1 | 9529 units |
| Z-2693-2017 | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.; AAD255.1 AAN997.1 AAP279.1 AAP328.1 AAP333.1 AAT509.1 AAT579.1 AAT582.1 AAT652.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT845.1 AAT902.1 AAT976.1 AAT987.1 AAT989.1 AAU003.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABA946.1 ABM329.1 ABM630.1 ABT798.1 ABT841.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE900.1 ACE936.1 ACE939.1 ACE994.1 ACF065.1 ACK145.1 ACK161.1 ACK241.1 ACK424.1 ACK511.1 ACK514.1 ACK549.1 ACK559.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP680.1 ACP686.1 ACP687.1 ACP700.1 ACP770.1 ACP780.1 ACP824.1 ACP833.1 ACP835.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACU349.1 ACU373.1 ACU381.1 ACU424.1 ADR679.1 ADR787.1 ADR794.1 ADR852.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH733.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH883.1 AEH951.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ106.1 AEJ111.1 AEJ145.1 AEJ148.1 AEJ164.1 AEJ167.1 AEJ203.1 AEJ241.1 AEJ251.1 AEJ252.1 AEJ257.1 AEM803.1 AEM833.1 AEM852.1 AEM857.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM917.1 AEM951.1 AEM964.1 AEM967.1 AEM969.1 AEM988.1 AFB225.1 AFB349.1 AFB376.1 AFB425.1 AFB433.1 AFB434.1 AFB436.1 AFB444.1 AFB454.1 AFB495.1 AFB658.1 AFG344.1 AFG446.1 AFG471.1 AFG496.1 AFG545.1 AFG668.1 AFG672.1 AFG679.1 AFG704.1 AFG724.1 AFG947.1 AFG959.1 AFZ174.1 AFZ211.1 AFZ224.1 AFZ260.1 AFZ359.1 AFZ364.1 AFZ384.1 AFZ409.1 AFZ427.1 AFZ532.1 AFZ588.1 AFZ590.1 AFZ807.1 AFZ835.1 AFZ851.1 AFZ996.1 AGM602.1 AGM732.1 AGM765.1 AGM950.1 AGN231.1 AGN324.1 AGN447.1 AGN490.1 AGN552.1 AGN616.1 AHD572.1 AHD578.1 AHD589.1 AHD612.1 AHD646.1 AHD648.1 AHD663.1 AHD677.1 AHD686.1 AHD713.1 AHD818.1 AHD821.1 AHD822.1 AHK567.1 AHK727.1 AHK778.1 AHK897.1 AHK906.1 AHK922.1 AHK976.1 AHL049.1 AHL054.1 AHL069.1 AHL093.1 AHL095.1 AHL097.1 AHL105.1 AHL122.1 AHL133.1 AHL135.1 AHL138.1 AHL195.1 AHV557.1 AHV591.1 AHV603.1 AHV679.1 AHV705.1 AHV797.1 AHV801.1 AHV802.1 AHV807.1 AHV810.1 AHV818.1 AHV824.1 AHV843.1 AHV851.1 AHV854.1 AHV855.1 AHV860.1 AHV873.1 AHV921.1 AHV937.1 AHV945.1 AHV947.1 AHV965.1 AHV971.1 AHV975.1 AHV992.1 AHW028.1 AHW049.1 AHW055.1 AHW080.1 AHW082.1 AHW085.1 AHW104.1 AHW156.1 AHW489.1 AHW492.1 AHW496.1 AHW498.1 AHW661.1 AHW663.1 AHW670.1 AHW683.1 AJP994.1 AJP995.1 AJR053.1 AJR058.1 AJR073.1 AJR075.1 AJR076.1 AJR077.1 AJW280.1 AJW285.1 AJW287.1 AJW290.1 AJW296.1 AJW310.1 AJW328.1 AJW329.1 AJW334.1 AJW336.1 AJW345.1 AJW365.1 AJW382.1 AJW384.1 AJW388.1 AJW393.1 AJW412.1 AJW422.1 AJW431.1 AJW461.1 AJW487.1 AKX628.1 ALE668.1 ALE944.1 ALJ257.1 ALJ402.1 ALJ928.1 ALJ984.1 ALJ992.1 ALN367.1 ALN378.1 ALN429.1 ALN438.1 ALN441.1 ALN444.1 ALN448.1 ALN451.1 ALN469.1 ALN477.1 ALN487.1 ALN547.1 ALN593.1 ALN596.1 ALN622.1 ALN628.1 ALN634.1 ALN658.1 ALX037.1 ALX043.1 ALX053.1 ALX085.1 ALX203.1 ALX313.1 ALY252.1 ALY270.1 ALY272.1 ALY313.1 ALY329.1 ALY367.1 ALY369.1 ALY371.1 ALY400.1 ALY431.1 ALY533.1 ALY544.1 ALY610.1 ALY624.1 ALY625.1 ALY636.1 ALY653.1 ALY660.1 ALY774.1 ALY778.1 ALY799.1 ALY801.1 ALY802.1 ALY810.1 ALZ039.1 ALZ051.1 ALZ064.1 ALZ080.1 ALZ311.1 AMK053.1 AMN786.1 AMN963.1 AMP153.1 AMP226.1 AMS002.1 AMS004.1 AMS007.1 AMS022.1 AMS024.1 AMS026.1 AMS038.1 AMS068.1 AMS073.1 AMS126.1 AMS127.1 AMS161.1 AMS169.1 AMS193.1 AMS228.1 AMS241.1 AMS248.1 AMS256.1 AMS258.1 AMS259.1 AMS270.1 AMS271.1 AMS400.1 AMS431.1 AMS879.1 AMT051.1 AMT260.1 AMT351.1 ANG969.1 ANG990.1 ANH036.1 ANH126.1 ANH170.1 ANH185.1 ANH258.1 ANH278.1 ANH468.1 ANH503.1 ANH603.1 ANH618.1 ANH636.1 ANL856.1 YY2921.1 YY5780.1 YY5876.1 YY6049.1 YY6118.1 YZ1385.1 YZ1487.1 YZ1509.1 YZ1511.1 YZ1514.1 YZ1515.1 YZ1531.1 YZ1574.1 YZ1595.1 YZ9624.1 YZ9636.1 YZ9648.1 YZ9651.1 YZ9654.1 YZ9683.1 YZ9691.1 YZ9702.1 YZ9709.1 YZ9712.1 YZ9713.1 YZ9724.1 YZ9732.1 YZ9749.1 YZ9755.1 YZ9768.1 YZ9826.1 YZ9857.1 ZK3232.1 ZK3240.1 ZK3253.1 ZK3370.1 ZV3919.1 ZW0254.1 ZW0302.1 ZW0587.1 ZW8865.1 ZW8885.1 ZW8943.1 ZW8991.1 ZY8811.1 ZY8821.1 ZY9321.1 ZY9369.1 ZY9406.1 | 443 units |
| Z-2694-2017 | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.; ALX120.1 ALX227.1 ALY287.1 ALY390.1 ALY471.1 ALY534.1 ALY560.1 ALY668.1 ALZ030.1 AMN762.1 AMN904.1 AMN990.1 AMP134.1 AMP169.1 AMP189.1 AMP246.1 AMS702.1 AMT135.1 AMT160.1 AMT357.1 ANG915.1 ANG951.1 ZA3446.1 ZA3511.1 ZB0872.1 ZB1144.1 ZB1181.1 ZB1188.1 ZB1190.1 ZB1200.1 ZB1213.1 ZB1218.1 ZB1225.1 ZB1422.1 ZB1463.1 ZB1507.1 ZK3289.1 ZS0594.1 ZS0699.1 ZS0772.1 ZW0246.1 ZW0268.1 ZW0273.1 ZW0283.1 ZW0364.1 ZW8776.1 ZW8796.1 ZW8863.1 ZW8879.1 ZW8887.1 ZW8904.1 ZW8965.1 ZW8972.1 ZX5593.1 | 54 units |
| Z-2695-2017 | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.; AAP149.1 AAP193.1 AAU029.1 ABA964.1 ACK581.1 ACK583.1 ACK784.1 ACK837.1 ACP794.1 ACT563.1 ACT591.1 ACT632.1 ACT645.1 ACT654.1 ACT684.1 ACT737.1 ACT895.1 ACU006.1 ACU060.1 ACU081.1 ACU085.1 ACU091.1 ACU165.1 ACU216.1 ACU220.1 ACU247.1 ADD484.1 ADD593.1 ADD633.1 ADD635.1 ADD647.1 ADD654.1 ADD668.1 ADD673.1 ADD681.1 ADD739.1 ADD754.1 ADD785.1 ADD786.1 ADD792.1 ADD808.1 ADD897.1 ADD904.1 ADD905.1 ADD910.1 ADD915.1 ADD946.1 ADD947.1 ADD970.1 ADD985.1 ADD995.1 ADE002.1 ADE014.1 ADE027.1 ADE030.1 ADE032.1 ADE073.1 ADE100.1 ADE104.1 ADE105.1 ADE129.1 ADE144.1 ADE152.1 ADJ719.1 ADK216.1 ADK261.1 ADK277.1 ADN241.1 ADN246.1 ADR337.1 ADR349.1 ADR353.1 ADR392.1 ADR399.1 ADR432.1 ADR435.1 ADR452.1 ADR467.1 ADR522.1 ADR545.1 ADR549.1 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 ADW463.1 ADW488.1 ADW495.1 ADW496.1 ADW497.1 ADW510.1 ADW566.1 ADW615.1 ADW675.1 ADW699.1 ADW720.1 ADW749.1 ADW754.1 ADW759.1 ADW767.1 ADW781.1 ADW790.1 ADW872.1 ADW876.1 ADW883.1 ADW912.1 ADW935.1 ADW983.1 ADW984.1 ADW998.1 AEH631.1 AEH637.1 AEH644.1 AEH648.1 AEH651.1 AEH654.1 AEH657.1 AEH670.1 AEH680.1 AEH699.1 AEH700.1 AEH702.1 AEH711.1 AEH721.1 AEH723.1 AEH729.1 AEH730.1 AEH746.1 AEH767.1 AEH770.1 AEH804.1 AEH815.1 AEH821.1 AEH825.1 AEH851.1 AEH853.1 AEH872.1 AEH875.1 AEH898.1 AEH938.1 AEH960.1 AEJ005.1 AEJ033.1 AEJ039.1 AEJ066.1 AEJ097.1 AEJ103.1 AEJ121.1 AEJ129.1 AEJ134.1 AEJ136.1 AEJ142.1 AEJ149.1 AEJ151.1 AEJ171.1 AEJ187.1 AEJ189.1 AEJ194.1 AEJ214.1 AEJ243.1 AEM754.1 AEM767.1 AEM777.1 AEM791.1 AEM795.1 AEM797.1 AEM799.1 AEM820.1 AEM851.1 AEM945.1 AEN031.1 AFB394.1 AFB395.1 AFB396.1 AFB404.1 AFB446.1 AFB903.1 AFB946.1 AFB996.1 AFG274.1 AFG376.1 AFG413.1 AFG429.1 AFG447.1 AFG452.1 AFG488.1 AFG501.1 AFG505.1 AFG535.1 AFG652.1 AFG663.1 AFG682.1 AFG689.1 AFG726.1 AFG730.1 AFG732.1 AFG742.1 AFG807.1 AFG823.1 AFG889.1 AFG895.1 AFG951.1 AFZ158.1 AFZ168.1 AFZ178.1 AFZ180.1 AFZ185.1 AFZ197.1 AFZ208.1 AFZ320.1 AFZ331.1 AFZ362.1 AFZ363.1 AFZ377.1 AFZ400.1 AFZ442.1 AFZ446.1 AFZ448.1 AFZ454.1 AFZ651.1 AFZ674.1 AHK715.1 AHW013.1 AKU960.1 AKV412.1 AKV505.1 AKV522.1 AKV546.1 AKV579.1 AKV608.1 AKV612.1 AKX057.1 AKX078.1 AKX170.1 AKX178.1 AKX201.1 AKX211.1 AKX233.1 AKX245.1 AKX266.1 AKX268.1 AKX271.1 AKX351.1 AKX374.1 AKX384.1 AKX430.1 AKX434.1 AKX690.1 AKX715.1 AKX739.1 AKX748.1 AKX750.1 AKX775.1 ALE569.1 ALE584.1 ALE588.1 ALE603.1 ALE604.1 ALE605.1 ALE624.1 ALE631.1 ALE675.1 ALE753.1 ALE774.1 ALE833.1 ALE881.1 ALE931.1 ALE956.1 ALF015.1 ALF030.1 ALF137.1 ALF156.1 ALF174.1 ALF176.1 ALF177.1 ALJ221.1 ALJ293.1 ALJ294.1 ALJ296.1 ALJ360.1 ALJ403.1 ALJ410.1 ALJ411.1 ALJ917.1 ALJ936.1 ALJ954.1 ALJ958.1 ALJ995.1 ALK043.1 ALN346.1 ALN387.1 ALN466.1 ALN475.1 ALN518.1 ALN543.1 ALN601.1 ALN609.1 ALN708.1 ALX040.1 ALX041.1 ALX095.1 ALX114.1 ALX116.1 ALX118.1 ALX127.1 ALX134.1 ALX153.1 ALX167.1 ALX206.1 ALX208.1 ALX214.1 ALX230.1 ALX235.1 ALX237.1 ALX285.1 ALX348.1 ALX385.1 ALX396.1 ALX398.1 ALX406.1 ALY302.1 ALY304.1 ALY423.1 ALY433.1 ALY505.1 ALY580.1 ALY818.1 ALY845.1 ALY846.1 ALZ312.1 AMP182.1 AMP197.1 AMS091.1 AMS109.1 AMS239.1 AMS294.1 AMS386.1 AMT046.1 AMT053.1 ANH074.1 ANH154.1 ANH416.1 ANL767.1 ANL971.1 ANM047.1 ANM057.1 ANM075.1 ANT216.1 ANT237.1 ANT270.1 ANT732.1 YS1152.1 YW0265.1 YY3065.1 ZB1268.1 ZB1298.1 ZV4047.1 ZX5856.1 ZY8853.1 ZY9066.1 ZY9124.1 ZY9485.1 | 373 units |
| Z-2696-2017 | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.; AAD257.1 AAD302.1 AAP362.1 AAP375.1 AAP385.1 ALX096.1 ALX257.1 ALX258.1 ALY268.1 ALY409.1 ALY435.1 ALY632.1 ALY640.1 ALY763.1 ALY780.1 ALY788.1 ALZ034.1 ALZ042.1 ANT267.1 ANT731.1 ZV3966.1 ZW0230.1 ZW0376.1 ZW0429.1 ZW0458.1 ZW0498.1 ZW0544.1 ZW0545.1 ZW0567.1 ZW0570.1 ZW0576.1 ZW0590.1 ZX5511.1 ZY9379.1 ZY9394.1 ZY9398.1 ZY9405.1 ZY9413.1 ZY9433.1 ZY9530.1 | 40 units |
What to do — step by step
Contact Your Doctor
Your physician can confirm if you have the recalled Infinity 7 implantable pulse generator and provide guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the device immediately?
No, the recall does not require immediate discontinuation. Patients should contact their doctor to determine if the device needs reprogramming or replacement.
Similar recalls
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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-2696-2017 (June 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2696-2017 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.