Medtronic recalls specific ICD models due to potential prevention of high and low voltage therapy. Affected devices may not treat life-threatening heart rhythms properly.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) that could prevent high and low voltage therapy. This means the devices might not properly treat dangerous heart rhythms, which could be life-threatening.
The devices may prevent high and low voltage therapy, which is critical for treating life-threatening heart rhythm issues like ventricular fibrillation. Without proper therapy, the device could fail to respond to dangerous heart rhythms.
People with the recalled ICD models (Visia AF VR ICD DF1 and DF4) are affected. Those with heart conditions requiring these devices are most at risk.
Check for the product numbers DVAB1D1 or DVAB1D4 on your device. The serial numbers include specific patterns like BWN201126H or BWP201614H.
Immediately stop using the recalled ICD models as they may not treat life-threatening heart rhythms properly.
Visia AF VR ICD DF1 (Product No. DVAB1D1) and Visia AF VR ICD DF4 (Product No. DVAB1D4).
Check the product number on your device; affected models have Product Numbers DVAB1D1 or DVAB1D4 with specific serial numbers.
Immediately stop using the device and contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0589-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0589-2018 from Medtronic. 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.
