Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
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 recall affecting critical cardiac devices with potential to fail during life-saving therapy delivery. Although no illnesses or deaths have been reported, the Class I designation and the serious risk posed by reduced or absent energy output during treatment warrant a Severe rating.
Plain-English summary
Medtronic Inc. is recalling its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DDMC3D1 (EVERA MRI S), manufactured with a specific glassed feedthrough component. Approximately 10,903 units have been distributed nationwide and internationally.
The recalled devices may fail to deliver adequate energy output during high-voltage therapy, typically administered at 0-12 joules. This rare defect could result in reduced or completely absent energy output when the device attempts to treat dangerous heart rhythms.
Patients who have these devices should contact Medtronic or their healthcare provider to confirm their device serial number and lot status against the recalled units. Patients should not discontinue using their device unless instructed by their healthcare provider, as the devices continue to perform other critical functions.
The recalled product
- Product
- ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- device-failure
- reduced-energy-output
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 00643169837737
- Lot Serial Numbers: CWC602314S
- CWC602130S
- CWC601890S
- CWC607466S
- CWC602236S
- CWC602359S
- CWC608108S
- CWC607103S
- CWC601544S
- CWC601546S
- CWC605273S
- CWC602965S
- CWC604941S
- CWC605039S
- CWC601687S
- CWC601688S
- CWC602560S
- CWC602845S
- CWC603176S
Distribution
Distributed nationwide across the United States.
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