BIOTRONIK recalls specific ILIVIA NEO 7 DR-T DF-1 ProMRI devices due to potential premature battery depletion in implantable cardiac devices. Affected units have unique serial numbers listed in the recall notice.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain ILIVIA NEO 7 DR-T DF-1 ProMRI implantable cardiac devices because they may deplete their batteries prematurely. This could cause the device to stop working properly, potentially leading to life-threatening heart rhythm issues.
The recalled devices may run out of battery power earlier than expected. This could cause the device to stop functioning, which might lead to life-threatening heart rhythm problems if the device fails to deliver necessary shocks or pacing.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled model are affected. Those with the specific serial numbers listed in the recall notice are most at risk.
Check if your device has the serial numbers listed in the recall notice: 61089430, 84703220, 84724608, and other numbers provided in the recall. The product is intended for ventricular tachycardia pacing and defibrillation in patients with life-threatening heart rhythm issues.
Look for the serial numbers listed in the recall notice (e.g., 61089430, 84703220, etc.) on your device.
BIOTRONIK recalls these devices because they may deplete their batteries prematurely, which could cause the device to stop working properly and lead to life-threatening heart rhythm issues.
Check your device's serial number against the list provided in the recall notice. If it matches, contact BIOTRONIK for further instructions.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1464-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1464-2021 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.
