Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 01…

Recall date

July 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2325-2025

FDA classification

Class I

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide Distribution. US nationwide. International distribution worldwide.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187