The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1801-2023·Announced 2023-06-28

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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)
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
21

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.

Part of a larger recall action

This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 120 products in this recall →

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