# FDA recall Z-2325-2025

> **Boston Scientific Corporation** · Class I · device recall initiated 2025-07-24.

## Product

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

## 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.

## Distribution

Worldwide Distribution. US nationwide. International distribution worldwide.

## Key facts

- **Recall number:** Z-2325-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-24
- **Report date:** 2025-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2025

## Citation

> AI Analytics. FDA recall Z-2325-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2325-2025. Source: US FDA. Licensed CC0.

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