Boston Scientific recalls ENDOTAK RELIANCE G/SG defibrillator leads with specific model numbers due to potential calcification 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 certain ENDOTAK RELIANCE G/SG defibrillator leads because they may calcify over time, leading to early replacement and potentially causing death or needing cardiac resuscitation. This recall affects patients with implanted defibrillators who use these specific model numbers.
The defibrillator leads may gradually calcify, causing rising LVSI measurements. This can lead to early lead replacement, which may result in death or the need for cardiac resuscitation if not addressed.
Patients with implanted defibrillators using the recalled ENDOTAK RELIANCE G/SG leads are most at risk. The recall applies to specific model numbers sold between 2019 and 2023.
Check the model number on the lead (0282, 0283, 0285, 0286, 0292, 0293, 0295, or 0296). The recall includes specific UDI-DI/GTIN codes listed in the product description.
Identify the model number on the defibrillator lead (0282, 0283, 0285, 0286, 0292, 0293, 0295, or 0296).
Reach out to your doctor or cardiac care team to discuss potential lead replacement if the model is recalled.
Model numbers 0282, 0283, 0285, 0286, 0292, 0293, 0295, and 0296 are affected.
The leads may calcify over time, causing rising LVSI measurements that could lead to early replacement and risk of death or cardiac resuscitation.
The recall does not require immediate replacement; however, affected patients should consult their healthcare provider about potential lead replacement.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2326-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2326-2025 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.
