Medtronic implantable cardioverter defibrillators recalled for potential reduced-output defect
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
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 an implanted life-critical cardiac device, which requires a minimum severity score of 4. Although no deaths or injuries have been reported, the potential for device malfunction during critical high-voltage therapy represents a serious risk to patient safety.
Plain-English summary
Medtronic Inc. has recalled the ICD-VR DVEX2E4 EV ICD model implantable cardioverter defibrillator (ICD) and related cardiac resynchronization therapy defibrillator (CRT-D) devices. The recall affects 21 units manufactured with a particular glassed feedthrough component.
The devices carry a rare potential for reduced or no-energy output during high-voltage (HV) therapy, typically delivering 0–12 joules. This malfunction could occur in currently available ICDs and CRT-Ds with the affected feedthrough design.
The recalled devices have been distributed nationwide in the United States and internationally. Patients with the affected lot serial numbers should contact their healthcare provider or Medtronic for guidance.
Individuals who may have received one of the recalled devices should consult with their physician to determine whether their specific device is affected and what monitoring or corrective action may be necessary.
The recalled product
- Product
- ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- output-failure
- device-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 00763000115647
- Lot Serial Numbers: EVR600484S
- EVR600487S
- EVR600488S
- EVR600489S
- EVR600490S
- EVR600492S
- EVR600494S
- EVR600479S
- EVR600480S
- EVR600483S
- EVR600500S
- EVR600495S
- EVR600496S
- EVR600478S
- EVR600516S
- EVR600517S
- EVR600519S
- EVR600521S
- EVR600522S
Distribution
Distributed nationwide across the United States.
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