Boston Scientific recalls Endotak Reliance G/SG defibrillation leads (model numbers 0160-0187) that may calcify, causing early lead replacement and risk of death or cardiac resuscitation.
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.
Boston Scientific is recalling Endotak Reliance G/SG defibrillation leads that may calcify over time, potentially requiring early replacement. This could lead to death or cardiac resuscitation if not addressed.
The leads may develop calcification, causing gradually rising LVSI measurements. This can lead to early lead replacement, which may result in death or cardiac resuscitation if the issue is not corrected.
Patients with implantable cardioverter defibrillators (ICDs) using the recalled Endotak Reliance G/SG leads are affected. Those with the specific model numbers listed are at risk of needing early lead replacement.
Check if your device is labeled with model numbers 0160 through 0187. The specific model numbers and UDI-DI/GTIN codes are listed in the recall notice.
Identify your device model number from the label on the lead.
Reach out to Boston Scientific for guidance on whether your device is affected and next steps.
Model numbers 0160 through 0187 are affected, including specific UDI-DI/GTIN codes listed in the recall notice.
The leads may calcify over time, causing gradually rising LVSI measurements that could lead to early replacement and risk of death or cardiac resuscitation.
The recall does not require immediate replacement; patients should contact Boston Scientific for guidance on whether their device needs attention.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2325-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2325-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
