Medtronic recalls specific models of CRTD CROME HF QUAD MRI IS4 DF4 implantable defibrillators with a glassed feedthrough. A rare potential for reduced or no energy output during high voltage therapy may occur. This recall affects devices with model number DTPC2QQ and specific serial numbers listed.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a specific glassed feedthrough. This rare issue could lead to reduced or no energy output during high voltage therapy, potentially affecting device function. If you own one of these models, you should contact Medtronic for further instructions.
The device uses a glassed feedthrough that can cause a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J). This may affect the device's ability to deliver proper therapy in emergencies.
People with Medtronic CRTD CROME HF QUAD MRI IS4 DF4 implantable defibrillators (model DTPC2QQ) and specific serial numbers listed in the recall. Those with these devices are most at risk.
Check if your device has model number DTPC2QQ and serial numbers listed in the recall (e.g., RTS600109S, RTS600115S, etc.). The recall includes specific GTIN 00763000178253 and lot/serial numbers provided.
Verify your device model number is DTPC2QQ and matches the serial numbers listed in the recall.
Reach out to Medtronic for instructions on next steps, as the recall does not specify a return or replacement process.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy. The risk is low and not expected to cause serious injury in normal use.
The recall does not specify a replacement or return process. Contact Medtronic for instructions.
The affected models are CRTD CROME HF QUAD MRI IS4 DF4 with model number DTPC2QQ and specific serial numbers listed in 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-1788-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1788-2023 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.