Recall Z-2326-2025— Boston Scientific Corporation

Name: FDA recall Z-2326-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-24

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2025-07-24. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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. Most serious harm is death or need for cardiac resuscitation..

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-07-24
Firm location: Saint Paul, MN, United States

Product description

ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296

Reason for recall

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. Most serious harm is death or need for cardiac resuscitation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.