Medtronic recalls Viva Quad S, Quad XT, S, and XT CRT-D defibrillators with specific product numbers and serials due to possible prevention of high and low voltage therapy.
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 Viva CRT-D defibrillators that may prevent high and low voltage therapy from working properly. This could lead to ineffective treatment of heart conditions.
These devices may prevent the proper delivery of high and low voltage therapy, which is critical for treating life-threatening heart rhythms. This could result in ineffective treatment of ventricular fibrillation or other arrhythmias.
People with implanted cardiac devices like CRT-Ds that match the listed product numbers and serials are affected. Those with heart conditions requiring defibrillation therapy are at highest risk.
Check your device's product number (e.g., DTBB1QQ) and serial number (e.g., BLK204122H) against the list provided in the recall notice. The devices are labeled as Viva CRT-D models.
Identify your device's product number and serial number to see if it matches the recalled models listed in the notice.
The recall does not specify an immediate stop-use action; check the device details against the list to determine if it is affected.
The recall notice does not provide specific action steps for affected devices beyond checking the details.
Compare your device's product number and serial number with the specific numbers listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0584-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0584-2018 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.