Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
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: This is an FDA Class I medical device recall, which by regulatory definition indicates a serious risk to health or safety. The Class I designation establishes the minimum severity threshold regardless of reported injuries. The potential for reduced therapy effectiveness in life-critical devices warrants the Severe classification.
Plain-English summary
Medtronic Inc. has issued a worldwide recall of certain Cobalt implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The recalled models are Cobalt XT HF CRT-D (Models DTPA2D4, DTPA2D1) and Cobalt XT HF Quad CRT-D (Models DTPA2QQ, DTPA2Q1). A total of 8,429 units have been identified as affected by this recall.
The devices have a potential defect that could result in reduced shock energy during high-voltage (HV) therapy, with affected devices potentially delivering approximately 79% of the programmed energy. This reduced energy output may impact the device's ability to successfully terminate life-threatening cardiac arrhythmias.
Patients implanted with affected devices are identified by specific serial numbers listed in the FDA recall notice. Healthcare providers should verify whether a patient's device is included in the recall by checking the device's serial number and model number. Patients with affected devices should consult with their implanting physician regarding appropriate follow-up and potential management options.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-shock-energy
- defibrillation-failure
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)
- a. Model Numbers: DTPA2D4: GTIN 00763000178130
- Serial Numbers: RTG600136S
- RTG600270S
- RTG601323S
- RTG601338S
- RTG601367S
- RTG601433S
- RTG601484S
- RTG601489S
- RTG601575S
- RTG601583S
- RTG601595S
- RTG601632S
- RTG601643S
- RTG601653S
- RTG601657S
- RTG601669S
- RTG601775S
- RTG601790S
- RTG601802S
Distribution
Distribution scope not specified by the agency.
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