Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.
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 have been reported, the potential for therapy failure in an implanted cardiac device that prevents life-saving defibrillation justifies this severe rating.
Plain-English summary
Medtronic has recalled 289 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DVEX3E4, due to a potential defect in a specific glassed feedthrough component.
The defect creates a rare potential that the device may produce reduced or no energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. This could prevent the device from delivering the intended electrical therapy to restore normal heart rhythm during cardiac events.
The affected devices were distributed nationwide in the United States and worldwide. Patients with affected ICDs or CRT-Ds are potentially at risk of inadequate therapy delivery in the event of a cardiac arrhythmia requiring defibrillation.
Patients who have received an affected device should contact their healthcare provider to discuss their individual risk and appropriate management options.
The recalled product
- Product
- ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-failure
- inadequate-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 00763000217891
- Lot Serial Numbers: EVS600719S
- EVS600271S
- EVS600272S
- EVS600273S
- EVS600274S
- EVS600322S
- EVS600324S
- EVS600325S
- EVS600326S
- EVS600366S
- EVS600372S
- EVS600503S
- EVS600504S
- EVS600529S
- EVS600530S
- EVS600531S
- EVS600547S
- EVS600548S
- EVS600623S
Distribution
Distributed nationwide across the United States.
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