Agency classClass IOur severity:Severe FDA (Devices)·Z-1812-2023·Announced 2023-06-28

Implantable Defibrillators May Have Reduced Energy Output During Therapy

Medtronic is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may produce reduced or no energy output during high-voltage therapy, potentially preventing treatment delivery.

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: FDA Class I classification indicates a serious health hazard (minimum score 4). The potential for reduced or no-energy output during critical therapy could be life-threatening, but no illnesses or deaths have been reported in the source documentation.

Plain-English summary

Medtronic Inc. is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DVMC3D1. These devices deliver high-voltage therapy to treat life-threatening abnormal heart rhythms.

The devices may have a rare defect in a specific feedthrough component that could cause reduced or no-energy output during high-voltage therapy (typically 0 to 12 joules). This defect could prevent the device from delivering the energy needed to correct the patient's dangerous heart rhythm.

The affected devices have been distributed nationwide and worldwide. Patients who have received one of these devices should contact their healthcare provider or Medtronic to discuss their individual situation. Do not make changes to heart medications or device settings without first consulting your doctor.

The recalled product

Product: ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Devices
Hazard: reduced-output
therapy-failure
device-malfunction
Affected units: 6,525

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 00643169837775
Lot Serial Numbers: CWF606066S
CWF601772S
CWF604835S
CWF604967S
CWF605332S
CWF601390S
CWF603522S
CWF602774S
CWF605900S
CWF600919S
CWF600938S
CWF601256S
CWF601551S
CWF601593S
CWF601753S
CWF601934S
CWF601936S
CWF602109S
CWF602581S

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 →

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

See all →

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Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
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Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · reduced output