Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DTMB1D1 due to rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Medtronic is recalling specific models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a rare risk of not delivering proper energy during high-voltage therapy. This could lead to ineffective treatment for heart conditions. Affected devices have specific model numbers and serial numbers listed in the recall.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in these devices. This could affect the device's ability to deliver necessary shocks for heart rhythm management, potentially leading to ineffective treatment of heart conditions.
Patients with Medtronic CRTD DTMB1D1 AMPLIA MRI US DF1 implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators are most at risk. The recall affects specific model numbers and serial numbers listed in the notice.
Check if your device has the model number DTMB1D1 and the listed serial numbers (RPV203851H through RPV601932S) or the GTIN 00643169837690. The recall covers specific production lots and serial numbers.
Verify your device's model number is DTMB1D1 and check if it matches the listed serial numbers or GTIN.
If your device is affected, contact Medtronic directly for further instructions on device replacement or repair.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness. However, this is not a common issue and the risk is low.
Check your device's model number and serial number against the list of affected units provided in the recall notice. Affected devices have model number DTMB1D1 and specific serial numbers listed in the recall.
The recall does not specify a replacement requirement; it states that affected devices should be checked with 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-1761-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1761-2023 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.
