Boston Scientific recalls EMBLEM MRI S-ICD Model A219 subcutaneous defibrillators with incorrect battery capacity display due to software timestamp issue. Affected units have specific serial numbers and UPN.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Boston Scientific is recalling EMBLEM MRI S-ICD Model A219 subcutaneous defibrillators because their software shows inaccurate battery capacity. This could lead to unexpected battery depletion and potential device failure, though it does not cause immediate harm.
The device's software has an incorrect manufacturing date/timestamp that causes it to display battery capacity inaccurately. This could lead to unexpected battery depletion and potential device failure, but it does not cause immediate harm or injury.
People with the EMBLEM MRI S-ICD Model A219 subcutaneous defibrillator implanted in their body. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device is labeled as EMBLEM MRI S-ICD Model A219, sterile. Affected units have specific serial numbers listed in the recall notice or UPN: 00802526584404 and 00802526581519.
Look for the serial number on your device's packaging or label to see if it matches the list of affected serial numbers provided in the recall.
If your device is affected, contact Boston Scientific directly for further instructions.
Boston Scientific recalls EMBLEM MRI S-ICD Model A219 devices because their software shows inaccurate battery capacity due to an incorrect manufacturing date/timestamp.
Check if your device has the specific serial numbers listed in the recall notice or UPN: 00802526584404 and 00802526581519.
No, the recall does not require immediate discontinuation of use. Affected devices may continue to function safely but should be checked with Boston Scientific.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0152-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0152-2023 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.
