Medtronic recalls specific models of CRT-D defibrillators that may prevent high and low voltage therapy, risking heart issues. Affected devices include Amplia MRI CRT-D models with certain serial numbers.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Medtronic is recalling specific models of cardiac defibrillators that may prevent proper heart therapy. This could lead to serious heart problems if the device fails to function correctly.
These devices may prevent high and low voltage therapy needed to treat heart conditions. If the device malfunctions, it could lead to life-threatening heart rhythm issues.
People with implanted Medtronic CRT-D defibrillators listed in the recall are affected. Those with the specific product numbers and serial numbers mentioned are most at risk.
Check your device label for the model name 'Amplia MRI CRT-D' and the specific product numbers (DTMB1D4, DTMB1Q1, DTMB1QQ, DTMB1D1) with matching serial numbers listed in the recall.
Look for the model name 'Amplia MRI CRT-D' and the specific product numbers (DTMB1D4, DTMB1Q1, DTMB1QQ, DTMB1D1) with matching serial numbers listed in the recall.
The recall affects Amplia MRI CRT-D models with specific product numbers: DTMB1D4, DTMB1Q1, DTMB1QQ, and DTMB1D1, each with listed serial numbers.
The recall does not specify a remedy, so no action is required unless you have the affected models listed in the recall.
The recall states that the device may prevent therapy, which could lead to serious heart issues, but no specific injury mechanism is described.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0582-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0582-2018 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.
