Reported Aug 27, 2025 · Ongoing
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model…
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?
ENDOTAK RELIANCE G/SG with 4-SITE Connectortransvenous defibrillation leadPermanent Defibrillator ElectrodesModel Nos. 02820283028502860292029302950296
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 008025264800960080252648576300802526504396— 00802526531248008025265417420080252655244100802526611186; Model 0293 UDI-DI/GTIN 00802526431449 00802526531255 00802526541827008025265525260080252655449000802526611179; Model 0295 UDI-DI/GTIN 00802526431463 00802526474699 00802526531262008025265419020080252655450600802526611131; Model 0296 UDI-DI/GTIN 00802526431470 00802526474705 008025264801640080252648018800802526531279— 0080252654198800802526552038— - 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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