Implantable Defibrillators Recalled for Rare Risk of Energy Output Failure
Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.
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 requires a minimum severity score of 4. Although no deaths or serious injuries have been reported and the hazard is described as a 'rare potential,' the Class I designation for a life-critical cardiac device with potential therapy failure warrants a Severe classification.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including the CRTD COBALT XT HF MRI IS1 DF4 model. Approximately 1,914 devices have been distributed in the United States and worldwide.
Devices manufactured with a specific electrical feedthrough component have a rare potential for reduced or no energy output during high voltage therapy, typically at 0-12 joules. This defect may prevent the devices from delivering the intended electrical therapy to manage heart rhythm.
Patients who have received these implanted devices are potentially affected. The FDA has classified this as a Class I recall, which indicates the reasonable probability that use of a defective product could cause serious adverse health consequences or death.
Patients with these devices should consult their healthcare provider to determine whether their device may be affected. Healthcare providers can verify device serial numbers against the recall lot numbers identified by Medtronic and the FDA.
The recalled product
- Product
- CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- defibrillator-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 00763000178130
- Lot Serial Numbers: RTG605297S
- RTG605299S
- RTG600588S
- RTG601635S
- RTG601691S
- RTG601840S
- RTG601857S
- RTG602986S
- RTG601966S
- RTG601364S
- RTG601621S
- RTG600270S
- RTG600554S
- RTG601405S
- RTG601699S
- RTG601977S
- RTG605270S
- RTG600137S
- RTG600138S
Distribution
Distributed nationwide across the United States.
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