Unrated Medical device recall · FDA · Published May 8, 2025
BALT USA Prestige Coil System Recall: Radiopaque Marker Not Visible During Angiography
BALT USA recalls Prestige Coil System models with specific REFs/UDI-DI codes due to radiopaque marker not being visible during angiography, potentially affecting medical procedures.
Recall notice
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Contact the company
Recalling firmBALT USA, LLC29 Parker Ste 100 · Irvine, CA 92618-1667
What happened, in plain English
BALT USA is recalling specific models of Prestige Coil System medical devices because the radiopaque marker used for imaging during procedures wasn't visible as it should be. This could lead to incorrect placement during angiography. Read more at govinfonow.com/recall/52324-balt-usa-prestige-coil-system-recall-radiopaque-marker-not-visible.
Source Summary by GovInfoNow · govinfonow.com/recall/52324-balt-usa-prestige-coil-system-recall-radiopaque-marker-not-visible · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1989-2025
Cite this page
“BALT USA Prestige Coil System Recall: Radiopaque Marker Not Visible During Angiography.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52324-balt-usa-prestige-coil-system-recall-radiopaque-marker-not-visible. Based on FDA recall #Z-1989-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1989-2025%22&limit=1).
Why it’s dangerous
The radiopaque marker is a visible marker that helps doctors see where the coil is placed during imaging. If it's not visible as it should be, doctors might place the coil incorrectly during angiography procedures, which could cause complications.
Who’s affected
Patients who have received the recalled Prestige Coil System models for medical procedures are at risk. Healthcare providers using these devices for angiography may need to check if their equipment is affected.
How to tell if you have this one
Check for the specific REFs/UDI-DI codes listed in the recall: PRES0153CXPPLT, PRES1045CPKPLT, PRES1245CPKPLT, etc. These codes are found on the product packaging or device labels.
- Brand
BALT USA- Category
Medical device
All 2 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
Ongoing- Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1988-2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.; Product Description/Product Catalog Number/UDI-DI/Lot Numbers: OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800506 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800507 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800579 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800885 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800480 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800581 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800722 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800857 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800858 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800854 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800855 OptiBLOCK Coil 2.5mm x 8cm OptiBLOCK Complex OPTI0258BLK 00810068568929 F230800768 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800514 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800525 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800577 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800770 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800887 OptiBLOCK Coil 2mm x 6cm OptiBLOCK Complex OPTI0206BLK 00810068568905 F230800478 OptiBLOCK Coil 3mm x 10cm OptiBLOCK Complex OPTI0310BLK 00810068568943 F230800497 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800760 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800856 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft OPTI0151HSS10 00818053026614 F230800784 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00840303701002 F230800453 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800452 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800542 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800543 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800801 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053022135 F230900938 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft OPTI0153HSS10 00840303701019 F230800521 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft OPTI0153HSS10 00818053026638 F230800496 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800679 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800762 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft OPTI0154HSS10 00840303701026 F230800813 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800852 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230900011 Optima Coil 10mm x 27cm Complex- 10 Standard OPTI1027CST10 00840303700142 F230800522 Optima Coil 10mm x 30cm Helical-10 Standard OPTI1030HST10 00818053027086 F230800668 Optima Coil 10mm x 30cm Helical-10 Standard OPTI1030HST10 00818053027086 F230800772 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053026461 F230800823 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053026461 F230800955 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053021978 F230900979 Optima Coil 11mm x 37cm Complex-18 OPTI1137COM18 00818053026478 F230800895 Optima Coil 11mm x 37cm Complex-18 OPTI1137COM18 00818053026478 F240500725 Optima Coil 15mm x 50cm Complex-18 OPTI1550COM18 00818053026515 F230800463 Optima Coil 15mm x 50cm Complex-18 OPTI1550COM18 00818053022029 F230900419 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800449 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800540 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800824 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 00840303700951 F230800960 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053025716 F230800562 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053025716 F230800692 Optima Coil 1mm x 2cm Helical-10 SuperSoft OPTI0102HSS10 00840303700968 F230800700 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053021381 F230900932 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800455 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800456 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800457 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800532 Optima Coil 1mm x 3cm Complex-10 SuperSoft OPTI0103CSS10 00818053025723 F230800942 Optima Coil 1mm x 3cm Complex-10 SuperSoft OPTI0103CSS10 00818053025723 F230800967 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053022104 F230900935 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800717 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800719 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800866 Optima Coil 2.5mm x 4cm Complex-10 SuperSoft OPTI0254CSS10 00840303700548 F230800561 Optima Coil 2.5mm x 4cm Complex-10 SuperSoft OPTI0254CSS10 00840303700548 F230800757 Optima Coil 2.5mm x 5cm Complex-10 Soft OPTI0255CSF10 00840303700203 F230800466 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800554 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800555 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800556 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800559 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800685 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800686 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800694 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230800725 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00840303701118 F230800726 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230800816 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00840303701118 F230800817 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800859 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230900016 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230900026 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053021510 F230900958 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053021510 F230900960 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F240500687 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00840303701040 F230800764 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00818053026669 F230800765 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00818053022173 F230900945 Optima Coil 2mm x 3cm Helical-10 SuperSoft OPTI0203HSS10 00840303701057 F230800573 Optima Coil 2mm x 3cm Complex-10 SuperSoft OPTI0203CSS10 00818053025785 F230800678 Optima Coil 2mm x 3cm Helical-10 SuperSoft OPTI0203HSS10 00840303701057 F230800706 Optima Coil 2mm x 4cm Complex-10 SuperSoft OPTI0204CSS10 00840303700494 F230800501 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00840303701064 F230800541 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00818053026683 F230800814 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00818053022197 F230900950 Optima Coil 2mm x 6cm Complex-10 Soft OPTI0206CSF10 00818053026027 F230800475 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800696 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800697 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800698 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800699 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800807 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230900012 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053021473 F230900951 Optima Coil 2mm x 8cm Complex-10 Soft OPTI0208CSF10 00818053026034 F230800468 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00840303701088 F230800572 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00840303701088 F230800733 Optima Coil 2mm x 8cm Complex-10 SuperSoft OPTI0208CSS10 00840303700517 F230800737 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00818053026706 F230800811 Optima Coil 2mm x 8cm Complex-10 SuperSoft OPTI0208CSS10 00818053025815 F230800903 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800484 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800531 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800798 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800965 Optima Coil 3mm x 10cm Helical-10 SuperSoft OPTI0310HSS10 00840303701156 F230800459 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00818053025907 F230800560 Optima Coil 3mm x 10cm Helical-10 Soft OPTI0310HSF10 00840303700814 F230800564 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00818053025907 F230800676 Optima Coil 3mm x 10cm Helical-10 Soft OPTI0310HSF10 00840303700814 F230800721 Optima Coil 3mm x 10cm Complex-10 Soft OPTI0310CSF10 00840303700234 F230800738 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00840303700609 F230800808 Optima Coil 3mm x 10cm Complex-10 Soft OPTI0310CSF10 00818053026072 F230800894 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00840303700609 F230900039 Optima Coil 3mm x 4cm Helical-10 SuperSoft OPTI0304HSS10 00840303701125 F230800460 Optima Coil 3mm x 4cm Helical-10 Soft OPTI0304HSF10 00840303700784 F230800499 Optima Coil 3mm x 4cm Complex-10 SuperSoft OPTI0304CSS10 00818053025877 F230800675 Optima Coil 3mm x 6cm Helical-10 SuperSoft OPTI0306HSS10 00840303701132 F230800571 Optima Coil 3mm x 6cm Helical-10 SuperSoft OPTI0306HSS10 00840303701132 F230800734 Optima Coil 3mm x 8cm Helical-10 SuperSoft OPTI0308HSS10 00840303701149 F230800461 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00818053026065 F230800473 Optima Coil 3mm x 8cm Helical-10 SuperSoft OPTI0308HSS10 00818053026768 F230800712 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00840303700227 F230800842 Optima Coil 3mm x 8cm Complex-10 SuperSoft OPTI0308CSS10 00840303700593 F230800850 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00840303700227 F230800959 Optima Coil 3mm x 8cm Complex-10 SuperSoft OPTI0308CSS10 00840303700593 F230900014 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800563 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800667 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800683 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800684 Optima Coil 4mm x 10cm Helical-10 Soft OPTI0410HSF10 00840303700852 F230800785 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800849 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800939 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800968 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053021602 F230900384 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053021602 F230900980 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00818053026119 F230800465 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800552 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800553 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800673 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800680 Optima Coil 4mm x 6cm Helical-10 SuperSoft OPTI0406HSS10 00840303701163 F230800800 Optima Coil 4mm x 6cm Helical-10 SuperSoft OPTI0406HSS10 00840303701163 F230800962 Optima Coil 4mm x 8cm Helical-10 SuperSoft OPTI0408HSS10 00818053026799 F230800820 Optima Coil 4mm x 8cm Helical-10 SuperSoft OPTI0408HSS10 00818053022302 F230900975 Optima Coil 4mm x13cm Complex- 10 Standard OPTI0413CST10 00840303700036 F230800724 Optima Coil 5mm x 10cm Helical-10 SuperSoft OPTI0510HSS10 00840303701217 F230800443 Optima Coil 5mm x 10cm Complex-10 SuperSoft OPTI0510CSS10 00840303700685 F230800783 Optima Coil 5mm x 10cm Helical-10 Soft OPTI0510HSF10 00840303700890 F230800964 Optima Coil 5mm x 13cm Complex-10 SuperSoft OPTI0513CSS10 00840303700692 F230800539 Optima Coil 5mm x 13cm Complex-10 SuperSoft OPTI0513CSS10 00818053025990 F230800902 Optima Coil 5mm x 17cm Complex-10 Soft OPTI0517CSF10 00818053026157 F230800476 Optima Coil 5mm x 17cm Complex- 10 Standard OPTI0517CST10 00840303700050 F230800758 Optima Coil 5mm x 8cm Complex-10 SuperSoft OPTI0508CSS10 00840303700678 F230800851 Optima Coil 5mm x 8cm Complex-10 SuperSoft OPTI0508CSS10 00840303700678 F230900034 Optima Coil 5mm x 9cm Complex-10 Soft OPTI0509CSF10 00818053026140 F230800547 Optima Coil 5mm x 9cm Complex-10 Soft OPTI0509CSF10 00840303700302 F230800705 Optima Coil 6mm x 10cm Helical-10 Soft OPTI0610HSF10 00840303700937 F230800500 Optima Coil 6mm x 11cm Complex-10 Soft OPTI0611CSF10 00818053026171 F230800469 Optima Coil 6mm x 11cm Complex-10 Soft OPTI0611CSF10 00818053021763 F230901000 Optima Coil 6mm x 20cm Complex-10 Soft OPTI0620CSF10 00840303700357 F230800470 Optima Coil 6mm x 20cm Complex-10 Soft OPTI0620CSF10 00840303700357 F230800548 Optima Coil 6mm x 20cm Helical-10 Standard OPTI0620HST10 00840303700715 F230800773 Optima Coil 7mm x 13cm Complex- 10 Standard OPTI0713CST10 00840303700081 F230800545 Optima Coil 7mm x 13cm Complex-10 Soft OPTI0713CSF10 00840303700364 F230800710 Optima Coil 7mm x 24cm Complex-10 Soft OPTI0724CSF10 00818053026218 F230800474 Optima Coil 7mm x 24cm Complex-10 Soft OPTI0724CSF10 00840303700371 F230800691 Optima Coil 7mm x 24cm Complex- 10 Standard OPTI0724CST10 00840303700098 F230800701 Optima Coil 7mm x 24cm Complex-18 OPTI0724COM18 00818053026430 F230800781 Optima Coil 7mm x 24cm Complex-18 OPTI0724COM18 00818053021947 F230901007 Optima Coil 8mm x 27cm Complex-10 Soft OPTI0827CSF10 00818053026232 F230800477 Optima Coil 8mm x 27cm Complex- 10 Standard OPTI0827CST10 00840303700111 F230800702 Optima Coil 8mm x 27cm Complex-10 Soft OPTI0827CSF10 00810068564105 F230900375 Optima Coil 9mm x 23cm Complex-10 Standard OPTI0923CST10 00818053026379 F230800464 Optima Coil 9mm x 23cm Complex-10 Standard OPTI0923CST10 00818053021893 F230900408 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053026454 F230800799 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053026454 F230800958 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053021961 F230900984 Optimax Coil 1.5mm x 3cm Helical OptiMAX Super Soft OPTI0153HSSMX 00818053025419 F230800666 Optimax Coil 10mm x 40cm Complex OptiMAX Soft OPTI1040CSFMX 00818053025280 F230800843 Optimax Coil 10mm x 40cm Complex OptiMAX Soft OPTI1040CSFMX 00818053025280 F230800966 Optimax Coil 12mm x 45cm Complex OptiMAX Soft OPTI1245CSFMX 00818053025303 F230800669 Optimax Coil 14mm x 45cm Complex OptiMAX Soft OPTI1445CSFMX 00818053025327 F230800695 Optimax Coil 16mm x 50cm Complex OptiMAX Soft OPTI1650CSFMX 00818053025341 F230800847 Optimax Coil 16mm x 50cm Complex OptiMAX Soft OPTI1650CSFMX 00818053025341 F230800935 Optimax Coil 1mm x 3cm Complex OptiMAX Super Soft OPTI0103CSSMX 00840303701408 F230800502 Optimax Coil 2.5mm x 2.5cm Complex OptiMAX Super Soft OPTI2525CSSMX 00840303701477 F230800446 Optimax Coil 2.5mm x 2.5cm Complex OptiMAX Super Soft OPTI2525CSSMX 00840303701477 F230800520 Optimax Coil 2.5mm x 5cm Complex OptiMAX Super Soft OPTI0255CSSMX 00818053025020 F230800495 Optimax Coil 2mm x 2cm Complex OptiMAX Super Soft OPTI0202CSSMX 00818053024979 F230800898 Optimax Coil 2mm x 2cm Complex OptiMAX Super Soft OPTI0202CSSMX 00818053024979 F230800900 Optimax Coil 3.5mm x 3.5cm Complex OptiMAX Super Soft OPTI3535CSSMX 00818053025068 F230800739 Optimax Coil 3mm x 10cm Complex OptiMAX Super Soft OPTI0310CSSMX 00818053025051 F230800896 Optimax Coil 3mm x 7cm Complex OptiMAX Super Soft OPTI0307CSSMX 00818053025044 F230800427 Optimax Coil 4.5mm x 10cm Complex OptiMAX Soft OPTI4510CSFMX 00818053025143 F230800826 Optimax Coil 4.5mm x 4.5cm Complex OptiMAX Soft OPTI4545CSFMX 00818053025136 F230800881 Optimax Coil 4.5mm x 4.5cm Complex OptiMAX Soft OPTI4545CSFMX 00818053025136 F230800937 Optimax Coil 4mm x 13cm Complex OptiMAX Soft OPTI0413CSFMX 00818053025129 F230800897 Optimax Coil 4mm x 4cm Complex OptiMAX Soft OPTI0404CSFMX 00818053025099 F230800767 Optimax Coil 4mm x 7cm Complex OptiMAX Soft OPTI0407CSFMX 00818053025105 F230800494 Optimax Coil 5mm x 10cm Complex OptiMAX Soft OPTI0510CSFMX 00818053025167 F230800901 Optimax Coil 5mm x 7cm Complex OptiMAX Soft OPTI0507CSFMX 00818053025150 F230800904 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800566 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800841 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800957 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800834 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800836 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800882 Optimax Coil 9mm x 30cm Complex OptiMAX Soft OPTI0930CSFMX 00818053025266 F230800840 | 2889 devices |
| Z-1989-2025 | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.; Product Description/Product Catalog Number/UDI-DI/Lot Numbers: PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800576 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800947 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800549 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800759 PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0258CXPPLT 00810068567380 F230800833 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800515 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800527 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800578 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800791 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800941 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800454 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800546 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800771 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800888 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800479 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800580 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800715 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800938 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F241100052 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800940 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800949 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800418 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800529 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800482 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800483 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800769 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800504 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800763 PRES0320CXPPLT Prestige 3mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0320CXPPLT 00810068567410 F230800441 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800795 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800796 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800451 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800664 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800797 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800831 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800822 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800886 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F241200132 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800458 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800517 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800511 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800519 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800766 PRES0650CPKPLT Prestige 6mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0650CPKPLT 00810068567571 F230800821 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800440 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800510 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800518 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800537 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800818 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230900021 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800444 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800509 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800665 PRES0830CPKPLT Prestige 8mm x 30cm (Ver. T) Prestige Plus Complex Pack PRES0830CPKPLT 00810068567618 F230800516 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800486 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800503 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800481 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800524 PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac PRES0204HXPPL 00818053029943 F230800782 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F230800809 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F240501011 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800863 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800864 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800865 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800879 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800880 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800815 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800890 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800892 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F241100535 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0307CXPPL 00818053027376 F230800746 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800861 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800862 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900036 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900037 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900038 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F241100975 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800889 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800893 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800438 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800447 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800498 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800704 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800943 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F241200129 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800445 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800569 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800448 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800467 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800570 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800727 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800810 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F230800565 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501363 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501600 PRES0750HPKPL Prestige Coil 7mm x 50cm Prestige Plus Helical Pack PRES0750HPKPL 00810068567861 F230800891 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F230800860 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F240501413 | 1754 devices |
What to do — step by step
Check Product Codes
Look for the specific REFs/UDI-DI codes listed in the recall on the product packaging or device labels.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maine, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1989-2025 (May 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1989-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.