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

ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI

ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this defibrillation lead action as Class I.

Plain-English summary

The ENDOTAK RELIANCE G/SG transvenous defibrillation lead, used with implantable cardioverter defibrillators, is being recalled across model numbers including 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185 and 0186, with UDI-DI numbers listed per model in the recall notice. The action covers 247,702 units in the United States and 344,670 outside the United States, with worldwide distribution.

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. The manufacturer states the most serious harm is death or the need for cardiac resuscitation. The FDA classified the action as Class I, its most serious category.

Clinicians should follow the manufacturer's advisory on monitoring affected leads. Patients with an implanted defibrillator lead should not change their care on their own and should speak to their cardiologist or implanting centre about whether they are affected.

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
Hazard
  • lead-calcification
  • impedance-rise
  • defibrillator-lead
  • class-i

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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