Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure

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

• therapy-failure
• device-malfunction
• cardiac-device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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