Boston Scientific recalls specific RELIANCE 4-FRONT defibrillator leads due to calcification risk. Early lead replacement may be needed to prevent 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 certain RELIANCE 4-FRONT defibrillator leads because they may calcify over time, leading to early replacement. This could cause death or require cardiac resuscitation if not addressed.
The leads may develop calcification, causing gradually rising LVSI measurements. This could lead to early lead replacement, potentially causing death or requiring cardiac resuscitation.
Patients with implanted defibrillator leads from the recalled models are affected. Those with the specific model numbers listed are most at risk.
Check if your defibrillator lead has model numbers 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, or 0696. Look for the UDI-DI codes listed in the recall notice.
Identify your defibrillator lead model number from the product list provided in the recall notice.
Reach out to Boston Scientific for guidance on next steps if your lead is affected.
The recalled leads may calcify over time, causing gradually rising LVSI measurements that could lead to early replacement, potentially causing death or requiring cardiac resuscitation.
Model numbers 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, and 0696 are affected.
The recall does not require immediate replacement; however, affected leads may need early replacement to prevent serious harm.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2327-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2327-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
