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

RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification

RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.

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 RELIANCE 4-FRONT endocardial cardioversion/defibrillation and pace/sense lead, a permanent defibrillator electrode, is being recalled across model numbers 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695 and 0696, 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
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 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 (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.

Related recalls

Same category