BIOTRONIK recalls specific models of implantable cardioverter defibrillators due to potential premature battery depletion. Affected devices may require replacement to prevent device failure.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain models of implantable cardioverter defibrillators (ICDs) because they may deplete their batteries prematurely. This could lead to device failure and potentially life-threatening arrhythmias if not addressed.
The recalled devices may deplete their batteries faster than expected, which could cause the device to stop working properly. This might lead to the inability to treat life-threatening heart rhythms, increasing the risk of serious health complications.
Patients with implantable cardioverter defibrillators (ICDs) who own the specific model numbers listed in the recall are affected. Those with the recalled devices are at risk of device failure.
Check your device's serial number against the list provided: 84736231, 84737026, 84737315, 84737560, 84738576, 84744864, 84744872, 84745476, 84748008, 84748843, 84749243, 84749246, 84751394, 84751632, 84753554, 84755167, 84761228.
Compare your device's serial number with the list provided in the recall: 84736231, 84737026, 84737315, 84737560, 84738576, 84744864, 84744872, 84745476, 84748008, 84748843, 84749243, 84749246, 84751394, 84751632, 84753554, 84755167, 84761228.
If your device is on the list, contact BIOTRONIK directly for instructions on device replacement or battery replacement.
The recalled devices may deplete their batteries prematurely, which could cause the device to stop working properly and fail to treat life-threatening heart rhythms.
Contact BIOTRONIK directly for instructions on device replacement or battery replacement.
Check your device's serial number against the list provided: 84736231, 84737026, 84737315, 84737560, 84738576, 84744864, 84744872, 84745476, 84748008, 84748843, 84749243, 84749246, 84751394, 84751632, 84753554, 84755167, 84761228.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1463-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1463-2021 from BIOTRONIK. 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.
