The Recall Desk
SevereFDA (Devices)·Z-1817-2023·Announced 2023-06-28

Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure

Medtronic's ICD-VR DVME3D4 defibrillators are recalled due to a rare risk of reduced or no energy output during high-voltage therapy. The defect involves a specific feedthrough component and affects approximately 14,989 units distributed nationwide and worldwide.

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 requires a minimum severity score of 4 per the rubric. Although no injuries or deaths are reported in the source text, the potential failure of a lifesaving cardiac device to deliver therapy during critical moments constitutes a severe hazard.

Plain-English summary

Medtronic Inc.'s ICD-VR DVME3D4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component are subject to an FDA Class I recall. Approximately 14,989 units have been distributed in the United States and worldwide.

There is a rare potential for reduced- or no-energy output during high-voltage (HV) therapy, typically ranging from 0 to 12 joules. If the device fails to deliver necessary therapy, it could prevent treatment of life-threatening abnormal heart rhythms and pose serious health risks to patients.

Patients who have received the affected ICD-VR DVME3D4 MIRRO MRI devices should consult with their healthcare provider or cardiologist to determine if their device is affected. Identification may be made through the device serial lot numbers provided in the recall notice.

Patients with an affected device should contact Medtronic or their implanting hospital immediately for evaluation and potential device replacement or corrective action. Do not discontinue use without consulting a physician, as this could present a direct health risk. Patients should follow their healthcare provider's guidance on the appropriate course of action.

The recalled product

Product
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Defibrillator
Hazard
Affected units
14,989

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 00763000001629
  • Lot Serial Numbers: CWR601226S
  • CWR601747S
  • CWR614516S
  • CWR615056S
  • CWR611693S
  • CWR610177S
  • CWR613808S
  • CWR600732S
  • CWR606430S
  • CWR602651S
  • CWR607356S
  • CWR610310S
  • CWR604045S
  • CWR603303S
  • CWR609623S
  • CWR605872S
  • CWR601687S
  • CWR603211S
  • CWR602807S

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 →

Related recalls

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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Same hazard · therapy failure

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