The Recall Desk
CriticalFDA (Devices)·Z-2327-2025·Announced 2025-08-27

Defibrillator leads recalled for calcification risk and potential device failure

Multiple models of RELIANCE 4-FRONT defibrillator leads may develop calcification, leading to device failure and potential cardiac emergencies.

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: This is an FDA Class I medical device recall. The source identifies death and the need for cardiac resuscitation as the most serious potential harms from the calcification defect.

Plain-English summary

Boston Scientific Corporation is recalling multiple models of its RELIANCE 4-FRONT defibrillation and pacing leads due to a calcification issue.

The affected leads may develop gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. This calcification may lead to early lead replacement. The most serious potential consequence is death or the need for cardiac resuscitation.

The recall affects 12 model numbers: 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, and 0696. Approximately 247,702 units were distributed in the United States and 344,670 units were distributed internationally.

The recalled product

Product
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
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Defibrillator Leads
Hazard
  • lead-calcification
  • device-failure

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 (8)

  • Model 0657 UDI-DI 00802526560934
  • Model 0682 UDI-DI 00802526560958
  • Model 0683 UDI-DI 00802526560965
  • Model 0685 UDI-DI 00802526560972
  • Model 0686 UDI-DI 00802526560989
  • Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688
  • Model 0695 UDI-DI 00802526519093 00802526561016
  • Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831

Distribution

Distributed nationwide across the United States.

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