Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This rare issue could affect device function during critical medical events.
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 use a glassed feedthrough. This rare issue could cause the device to fail during high voltage therapy, potentially affecting critical heart rhythm management. Affected devices may need replacement.
The device uses a glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This rare issue may prevent the device from delivering necessary shocks during critical heart rhythm events, potentially leading to device failure.
People with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough (model DDMB2D4) are most at risk. This recall affects individuals who have these devices implanted for heart rhythm management.
Check your device model number: DDMB2D4. Look for the lot/serial numbers listed in the recall (PGZ624363S through PGZ643999S). This recall applies to specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a glassed feedthrough.
Verify your device model number is DDMB2D4. This recall applies to specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Check if your device's lot/serial number matches the list provided in the recall (PGZ624363S through PGZ643999S).
No action is needed if your device model and serial number are not in the recall list.
This is a rare issue that may cause reduced or no energy output during high voltage therapy, potentially affecting device function during critical heart rhythm events.
The recall does not specify a replacement process or remedy. Contact Medtronic directly 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-1714-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1714-2023 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.
