Reported Aug 27, 2025 · Ongoing
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes;…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published 065700802526560934UDI-DI 00802526560934 068200802526560958UDI-DI 00802526560958 068300802526560965UDI-DI 00802526560965 068500802526560972UDI-DI 00802526560972 068600802526560989UDI-DI 00802526560989 069200802526519017008025265609960080252656866400802526568688UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688 06930080252651885000802526519055008025265377690080252656100900802526568701UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701 06950080252651909300802526561016UDI-DI 00802526519093 00802526561016 0696008025265199870080252656120700802526568831UDI-DI 00802526519987 00802526561207 00802526568831 - Amount recalled
- 247,702 US; 344,670 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.