BIOTRONIK recalls Iperia 7, DR-T, DF-1, and ProMRI devices due to potential premature battery depletion in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain Iperia 7, DR-T, DF-1, and ProMRI devices because they may experience premature battery depletion. This could lead to the device stopping working when needed to treat life-threatening heart rhythms.
The devices may run out of battery power before the intended lifespan, which could cause the device to stop functioning when it's needed to treat life-threatening heart rhythm issues. This is a risk during normal use but does not cause immediate harm.
Individuals with implanted Iperia 7, DR-T, DF-1, or ProMRI devices that have the listed serial numbers are affected. Patients with these devices are at risk if the battery depletes prematurely.
Check if your device has a serial number listed in the provided range (e.g., 60824474, 60824475, etc.). The devices are intended for ventricular tachycardia pacing and defibrillation.
Look for the serial number on your device's label and compare it to the list of affected serial numbers provided in the recall notice.
If your device is affected, contact BIOTRONIK directly for further instructions on how to address the issue.
The affected devices are BIOTRONIK Iperia 7, DR-T, DF-1, and ProMRI models with the specific serial numbers listed in the recall notice.
The recall states there is a potential for premature battery depletion, which could cause the device to stop working when needed. However, this does not cause immediate injury and is not a risk of serious injury in normal use.
Check your device's serial number against the list of affected serial numbers provided in the recall notice.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1446-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1446-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
