The Recall Desk
SevereFDA (Devices)·Z-2325-2025·Announced 2025-08-27

Defibrillation Leads Risk Early Replacement From Coil Calcification

Boston Scientific's ENDOTAK RELIANCE defibrillation leads may develop coil calcification causing gradually rising electrical impedance measurements. This condition may require early lead replacement; most serious outcomes include cardiac emergency or death.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of an implantable cardiac device. Although the source does not report documented illnesses or deaths, the potential for serious outcomes including death and cardiac emergency, combined with the Class I regulatory classification, meets the criteria for a Severe rating (minimum score of 4 for Class I recalls).

Plain-English summary

Boston Scientific Corporation is recalling certain models of ENDOTAK RELIANCE G/SG transvenous defibrillation leads used in implantable cardioverter defibrillators (ICDs). These leads are distributed worldwide, including throughout the United States.

The affected defibrillation lead coils may develop calcification, causing LVSI measurements to gradually increase. This condition may lead to early lead replacement. The most serious potential harm is death or need for cardiac resuscitation.

Patients who have received these leads should contact their healthcare provider or Boston Scientific Corporation for guidance on whether their device is affected and what actions may be necessary.

This FDA Class I recall reflects the serious potential for device malfunction in a critical implantable cardiac device.

The recalled product

Product
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
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Implant / Defibrillation Lead
Hazard
  • device-failure
  • calcification
  • cardiac-event

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Model 0161 UDI-DI/GTIN 00802526372766
  • Model 0164 UDI-DI/GTIN N/A
  • Model 0165 UDI-DI/GTIN 00802526377259
  • Model 0167 UDI-DI/GTIN N/A 00802526373251
  • Model 0170 UDI-DI/GTIN 00802526373282 00802526373299
  • Model 0171 UDI-DI/GTIN 00802526373374 00802526373381
  • Model 0172 UDI-DI/GTIN 00802526373466
  • Model 0173 UDI-DI/GTIN 00802526373558 00802526373565
  • Model 0174 UDI-DI/GTIN 00802526373640
  • Model 0175 UDI-DI/GTIN 00802526373732 00802526373749
  • Model 0176 UDI-DI/GTIN 00802526376726 00802526376733
  • Model 0177 UDI-DI/GTIN 00802526376818 00802526376825
  • Model 0182 UDI-DI/GTIN 00802526422041 00802526531163
  • Model 0183 UDI-DI/GTIN 00802526422058 00802526531170
  • Model 0187 UDI-DI/GTIN 00802526412042 00802526422096 00802526531217

Distribution

Distributed nationwide across the United States.

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