Boston Scientific recalls EMBLEM MRI S-ICD Pulse Generator models with serial numbers from 213636 to 214085 (7/21/2019 to 7/31/2019) due to potential accelerated battery depletion requiring earlier replacement.
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 EMBLEM MRI S-ICD Pulse Generators with specific serial numbers because an electrical component may cause the battery to deplete faster than expected, requiring earlier replacement. This could lead to the device needing replacement sooner than intended, which is important for patients with implanted defibrillators.
The electrical component in the device may cause the battery to deplete faster than expected, leading to the need for earlier replacement than intended. This could potentially cause the device to malfunction before its scheduled replacement time.
Patients with Boston Scientific EMBLEM MRI S-ICD Pulse Generators (model A219) and the specific serial numbers listed in the recall. Those most at risk are individuals who have the device implanted and are using the recalled model.
Check if your device is labeled as EMBLEM MRI S-ICD Pulse Generator with model A219 and serial numbers from 213636 to 214085 (sold with use before dates from July 21, 2019, to July 31, 2019).
Reach out to Boston Scientific directly to confirm if your device is affected and get instructions for replacement.
The recall states the device may need replacement earlier than expected due to battery depletion, but the exact timing depends on the device's condition and the manufacturer's guidance.
Contact Boston Scientific directly to confirm if your device is affected and get instructions for replacement.
The recall indicates potential battery depletion requiring earlier replacement, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2543-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2543-2019 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.
