Medtronic recalls specific implantable cardioverter defibrillators (CRTDs) with model DTPB2Q1 due to rare potential for reduced or no energy output during high voltage therapy. This could affect device function but is not expected to cause injury.
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 (CRTDs) with model number DTPB2Q1. 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 not expected to cause injury but requires monitoring.
The device uses a specific glassed feedthrough that can occasionally fail to deliver energy during high voltage therapy (typically 0-12J). This is a rare occurrence and does not cause injury but may require the device to be reprogrammed or replaced.
People with Medtronic implantable cardioverter defibrillators (CRTDs) that have model number DTPB2Q1 and the listed serial numbers or lot numbers. Those with the specific model and serial numbers are most at risk.
Check if your device has model number DTPB2Q1 and serial numbers starting with RTL60 followed by 6 digits (e.g., RTL600234S). The device is also identified by GTIN 00763000178185 and lot numbers listed in the recall.
Identify your device model number and serial number to see if it matches the recalled model DTPB2Q1 and the listed serial numbers.
If your device is affected, contact Medtronic directly for instructions on how to proceed with the recall.
This recall involves a rare potential for reduced or no energy output during high voltage therapy, but it is not expected to cause injury. The device may need reprogramming or replacement.
Your device is affected if it has model number DTPB2Q1 and serial numbers starting with RTL60 followed by 6 digits (e.g., RTL600234S).
Contact Medtronic directly for instructions on how to proceed with the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1783-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1783-2023 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.