Boston Scientific recalls S-ICD Pulse Generators with specific serial numbers due to potential accelerated battery depletion requiring earlier replacement than expected.
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
Boston Scientific is recalling certain S-ICD Pulse Generators that may need replacement sooner than expected because of a problem with the battery. This could lead to the device failing to work properly and not providing life-saving shocks if needed.
The device's electrical component may cause the battery to deplete faster than normal, leading to the device needing replacement earlier than expected. This could mean the device fails to deliver life-saving shocks during a cardiac emergency.
People with a Boston Scientific S-ICD Pulse Generator (model A209) that has one of the listed serial numbers are affected. Those who have the device implanted and are at risk of cardiac issues are most vulnerable.
Check the serial number on your S-ICD Pulse Generator. The affected units have specific serial numbers listed in the recall, with use dates between July 24-31, 2019.
Look for the serial number on the device, which should match one of the listed numbers in the recall (e.g., 213729, 213859, etc.).
If your device is affected, contact Boston Scientific directly for instructions on replacement or repair.
The recall is for potential accelerated battery depletion due to a compromised electrical component, which may require earlier replacement than expected.
No, but you should contact Boston Scientific to determine if your device needs replacement sooner than expected.
Check the serial number against the list provided and contact Boston Scientific for replacement 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-2542-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2542-2019 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.
