The Recall Desk
CriticalFDA (Devices)·Z-2326-2025·Announced 2025-08-27

ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification

ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector 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 with 4-SITE Connector, a permanent defibrillator electrode, is being recalled across model numbers 0282, 0283, 0285, 0286, 0292, 0293, 0295 and 0296, 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 with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
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 (4)

  • Model 0282 UDI-DI/GTIN 00802526431371
  • Model 0283 UDI-DI/GTIN 00802526431388 00802526504181
  • Model 0285 UDI-DI/GTIN 00802526431401
  • Model 0286 UDI-DI/GTIN 00802526431418

Distribution

Distributed nationwide across the United States.

Related recalls

Same category