Agency classClass IOur severity:Critical FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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.

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Boston Scientific Corporation

See all →

Moderate
Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · lead calcification