Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include EVERA XT DR GOLD CTD with specific serial numbers.
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 certain implantable cardioverter defibrillators (ICDs) that have a rare risk of not delivering enough energy during high voltage therapy. This could potentially lead to inadequate treatment for heart conditions. Affected devices have specific model numbers and serial numbers.
The device uses a specific type of glassed feedthrough that can sometimes fail to deliver the required energy during high voltage therapy. This is a rare occurrence but could result in inadequate treatment for heart conditions if the device fails to function properly.
People with implanted cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the specific model described in the recall. Those with the model number DDBB1D4G and serial numbers starting with BWB232002H are most at risk.
Check if your device has the model number DDBB1D4G and serial numbers starting with BWB232002H. The product is identified by GTIN 00643169518216.
Verify your device's model number and serial number to confirm if it matches the recalled items (DDBB1D4G and serial numbers starting with BWB232002H).
The recall does not require immediate stop use; however, you should check if your device is affected and follow the provided steps.
The affected model number is DDBB1D4G.
Check for the model number DDBB1D4G and serial numbers starting with BWB232002H.
We’ve drafted a message you can send Medtr: CRHF to request your refund or repair — edit it as you like.
Subject: Recall Z-1706-2023 — Medtr: CRHF Medtr: CRHF Hello, I own a Medtr: CRHF that is covered by recall Z-1706-2023 from Medtr: CRHF. 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.
