Cardioverter Defibrillators Recalled: Potential Reduced or No-Energy Output
Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.
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 FDA Class I recall requires a minimum Severe rating per the FDA classification rule. The potential for therapy failure in life-critical situations, combined with FDA Class I designation, justifies the Severe rating despite no reported injuries to date.
Plain-English summary
Medtronic has issued a Class I recall for certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The defect involves a specific type of feedthrough component that can affect therapy delivery.
The potential for reduced or no-energy output during high-voltage therapy poses a serious risk to patients who depend on their devices for cardiac protection. Although no injuries or deaths have been reported to date, the condition could prevent proper defibrillation when needed.
Patients with affected devices should contact Medtronic immediately. The company has provided a list of affected lot serial numbers spanning both US and worldwide distribution. Healthcare providers should work with patients to determine if their devices are affected and discuss appropriate management options.
The recalled product
- Product
- CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-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)
- GTIN 00643169720749
- Lot Serial Numbers: RPL202320H
- RPL202797H
- RPL202825H
- RPL203304H
- RPL203279H
- RPL203319H
- RPL203730H
- RPL203754H
- RPL204075H
- RPL202479H
- RPL202565H
- RPL202842H
- RPL203342H
- RPL203518H
- RPL203521H
- RPL203522H
- RPL203534H
- RPL203543H
- RPL203556H
Distribution
Distributed nationwide across the United States.
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