ENDOTAK RELIANCE G/SG — Class I medical device recall Z-2325-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-08-27, distributed nationwide. Affected lead models may experience gradually rising LVSI measurements in association with calcification of th
| Recall number | Z-2325-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2025-07-24 |
| Classified | 2025-08-20 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00802526372766, 00802526373251, 00802526373282, 00802526373299, 00802526373374, 00802526373381, 00802526373466, 00802526373558, 00802526373565, 00802526373640, 00802526373732, 00802526373749, 00802526376726, 00802526376733, 00802526376818, 00802526376825, 00802526377259, 00802526411977, 00802526411984, 00802526412011, 00802526412028, 00802526412035, 00802526412042, 00802526413438, 00802526422027 and 43 more |
| Model numbers | 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, O182 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.