Medtronic recalls certain implantable cardioverter defibrillators (ICDs) with model number DDPB3D1 due to rare potential for reduced or no energy output during high voltage therapy. This may affect safety of the device.
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 implantable cardioverter defibrillators (ICDs) with model number DDPB3D1. These devices have a rare potential for reduced or no energy output during high voltage therapy, which could affect their ability to properly treat heart conditions. This is a safety issue that requires attention.
The device uses a specific type of glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not deliver the necessary electrical shocks to treat heart arrhythmias in certain situations.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that match the specific model number and serial numbers listed in the recall. Patients with these devices are most at risk.
Check if your ICD has model number DDPB3D1 and serial numbers listed in the recall (e.g., RSN600341S, RSN601060S, etc.). The device is also identified by GTIN 00763000178376 and GTIN 00763000178383.
Look for the model number DDPB3D1 on your ICD device.
Check if your device's serial number matches any listed in the recall (e.g., RSN600341S, RSN601060S, etc.).
If you have the device, contact Medtronic directly for further instructions.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy. It is not expected to cause serious injury but requires attention to ensure device safety.
Check if your device has model number DDPB3D1 and a serial number listed in the recall (e.g., RSN600341S, RSN601060S, etc.).
Contact Medtronic directly for further instructions on how to address the issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1725-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1725-2023 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.
