Medtronic's ICD COBALT DR MRI IS1 DF4 model (DDPB3D4) with certain serial numbers may have reduced energy output during high voltage therapy, potentially causing ineffective defibrillation. Affected units include specific serial numbers listed in the recall.
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's ICD COBALT DR MRI IS1 DF4 models (DDPB3D4) with certain serial numbers may have a rare risk of reduced or no energy output during high voltage therapy. This could lead to ineffective defibrillation if the device needs to shock the heart. The risk is very low but should be addressed.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver the full energy needed during high voltage therapy (0-12J). This might result in ineffective defibrillation if the device needs to shock the heart during a life-threatening arrhythmia.
People with Medtronic ICD COBALT DR MRI IS1 DF4 implants (model DDPB3D4) who have the listed serial numbers are affected. The risk is very low and only occurs in rare cases during high voltage therapy.
Check if your device is labeled as 'ICD COBALT DR MRI IS1 DF4' with model number DDPB3D4. Look for the serial numbers listed in the recall (e.g., RSO600207S, RSO600934S, etc.).
Look for the serial number on your device's label, which should match one of the listed serial numbers in the recall.
If your device is affected, contact Medtronic directly to discuss next steps and potential remedies.
This is a rare risk of reduced energy output during high voltage therapy, which could lead to ineffective defibrillation in very specific circumstances. The risk is very low and not a common issue.
Your device is affected if it is labeled as 'ICD COBALT DR MRI IS1 DF4' with model number DDPB3D4 and has one of the listed serial numbers (e.g., RSO600207S, RSO600934S, etc.).
Contact Medtronic directly to discuss next steps and potential remedies. The recall does not include a specific fix or replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1726-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1726-2023 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.
