Reported Aug 27, 2025 · Ongoing
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos.…
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, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
- Lot codes and dates
20 of 20 products
Products covered by this recall Model / number Barcodes Product as published 00802526372766Model 0161 UDI-DI/ 0164UDI-DI/GTIN N/A 00802526377259Model 0165 UDI-DI/ 016700802526373251UDI-DI/GTIN N/A 00802526373251 0080252637328200802526373299Model 0170 UDI-DI/ 00802526373299 0080252637337400802526373381Model 0171 UDI-DI/ 00802526373381 00802526373466Model 0172 UDI-DI/ 0080252637355800802526373565Model 0173 UDI-DI/ 00802526373565 00802526373640Model 0174 UDI-DI/ 0080252637373200802526373749Model 0175 UDI-DI/ 00802526373749 0080252637672600802526376733Model 0176 UDI-DI/ 00802526376733 0080252637681800802526376825Model 0177 UDI-DI/ 00802526376825 00802526411977008025264220270080252643359700802526531149008025265409430080252654095000802526591518Model 0180 UDI-DI/ 00802526422027 00802526433597 00802526531149 00802526540943 00802526540950 00802526591518 0080252641198400802526422034008025264336890080252643372600802526433757008025264910090080252650290300802526531156Model 0181 UDI-DI/ 00802526422034 00802526433689 00802526433726 00802526433757 00802526491009 00802526502903 00802526531156 0080252642204100802526531163Model 0182 UDI-DI/ 00802526531163 0080252642205800802526531170Model 0183 UDI-DI/ 00802526531170 0080252641201100802526422065008025264339860080252643399300802526491313008025265311870080252654126100802526583438Model 0184 UDI-DI/ 00802526422065 00802526433986 00802526433993 00802526491313 00802526531187 00802526541261 00802526583438 0080252641202800802526413438008025264220720080252643408200802526434099008025264341050080252643415000802526434174008025264706220080252649140500802526491412008025264914290080252650330600802526531194008025265413460080252659156300802526612541Model 0185 UDI-DI/ 00802526413438 00802526422072 00802526434082 00802526434099 00802526434105 00802526434150 00802526434174 00802526470622 00802526491405 00802526491412 00802526491429 00802526503306 00802526531194 00802526541346 00802526591563 00802526612541 00802526412035008025264220890080252643419800802526531200Model 0186 UDI-DI/ 00802526422089 00802526434198 00802526531200 008025264120420080252642209600802526531217Model 0187 UDI-DI/ 00802526422096 00802526531217 - 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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