BIOTRONIK recalls specific models of implantable 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 implantable defibrillator models because they may deplete their batteries prematurely. This could lead to device failure and potentially life-threatening complications if the device stops working.
The recalled devices may run out of battery earlier than expected, which could cause the device to stop functioning. This might prevent the device from treating life-threatening heart rhythms, increasing the risk of serious cardiac events.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled models are affected. Those with the specific serial numbers listed are at risk.
Check the product's serial number on the device or packaging. The recalled models have specific serial numbers listed in the recall notice, including the range starting with 84733171 through 84761780.
Look for the serial number on the device or its packaging to confirm if it's in the list of affected numbers provided in the recall notice.
Reach out to BIOTRONIK directly for guidance on next steps if the device is confirmed affected.
BIOTRONIK recalls these devices due to a potential risk of premature battery depletion, which could cause the device to stop working and fail to treat life-threatening heart rhythms.
Check the device's serial number against the list provided in the recall notice. If affected, contact BIOTRONIK for further instructions.
Yes, the affected models include the BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI with serial numbers ranging from 84733171 to 84761780.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1462-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1462-2021 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.
