Boston Scientific recalls EMBLEM S-ICD subcutaneous defibrillators with incorrect battery capacity display due to software timestamp issue. Affected units have specific serial numbers.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Boston Scientific is recalling EMBLEM S-ICD subcutaneous defibrillators model A209 because their software shows inaccurate battery capacity. This could lead to unexpected battery depletion and potential device failure.
The software contains an incorrect manufacturing date/timestamp that causes the device to display inaccurate battery capacity. This could result in the battery depleting unexpectedly, potentially causing device failure.
Patients with EMBLEM S-ICD model A209 defibrillators who have the listed serial numbers are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your EMBLEM S-ICD defibrillator has the serial numbers: 169276, 169509, 169645, 169774, 169876, 169671, or 169297. The product was sold with the specific model and sterile packaging.
Verify your EMBLEM S-ICD model A209 has one of the listed serial numbers: 169276, 169509, 169645, 169774, 169876, 169671, or 169297.
The specific model is EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209.
Check if your device has one of the serial numbers: 169276, 169509, 169645, 169774, 169876, 169671, or 169297.
The recall does not specify a remedy, so contact Boston Scientific directly for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0151-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0151-2023 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.
