Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough design issue. This could prevent life-saving electrical therapy from being delivered.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of 4 per the rubric. Although no illnesses or injuries are reported in the source and the risk is described as rare and potential, the serious nature of the failure mode—inability to deliver life-saving electrical cardiac therapy—justifies the Severe classification.
Plain-English summary
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMC2D4. These devices are designed to deliver electrical therapy to correct abnormal heart rhythms.
A rare potential exists for reduced or no-energy output during high voltage therapy (typically 0-12J) in devices manufactured with a specific feedthrough design. This means the device may fail to deliver the electrical pulse needed to correct abnormal heart rhythms.
Approximately 11,375 units have been distributed nationwide and worldwide. Patients with these affected devices may be at risk of the device failing to function when life-saving therapy is needed.
Patients with these devices should consult their healthcare provider to determine if their device is affected and discuss appropriate monitoring or replacement options.
The recalled product
- Product
- CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169720701
- Lot Serial Numbers: RPH603922S
- RPH608147S
- RPH603531S
- RPH607413S
- RPH607373S
- RPH604394S
- RPH606758S
- RPH603572S
- RPH606941S
- RPH603152S
- RPH603203S
- RPH603999S
- RPH604021S
- RPH606976S
- RPH603841S
- RPH604928S
- RPH605779S
- RPH605780S
- RPH606559S
Distribution
Distributed nationwide across the United States.
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