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 defibrillators that could run out of battery prematurely. This could cause the device to stop working, which might not be safe for users with heart conditions.
The defibrillators may deplete their batteries faster than expected, leading to device failure. If the device stops working, it could not treat life-threatening heart rhythms, which is dangerous for users.
People with implantable defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled models. Those with heart conditions requiring these devices are most at risk.
Check the serial numbers listed: 84737505, 84737521, 84738497, 84738498, 84738995, 84738997, 84739001, 84739004. The product is a specific model of implantable defibrillator sold for heart rhythm treatment.
Look for the serial numbers listed: 84737505, 84737521, 84738497, 84738498, 84738995, 84738997, 84739001, 84739004.
The recall is due to a potential for premature battery depletion in these implantable defibrillators, which could cause the device to stop working.
Check the serial number against the list provided. If it matches, contact BIOTRONIK for further instructions.
Yes, if the device stops working, it may not treat life-threatening heart rhythms, which is dangerous for users with heart conditions.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1465-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1465-2021 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.