Agency classClass IOur severity:Severe FDA (Devices)·Z-1796-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.

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 reasonable probability of serious adverse health consequences. Device failure during critical therapy could prevent life-saving defibrillation, though no reported deaths or serious injuries are documented in the source material.

Plain-English summary

Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component. The FDA has classified this as a Class I recall.

The recalled devices may fail to deliver the necessary energy during high-voltage therapy (typically 0-12 joules), which is designed to treat dangerous heart rhythms. This failure could prevent the device from delivering life-saving defibrillation therapy during a cardiac emergency.

The recall affects 4 units with lot serial numbers BWH224619H, BWH224621H, BWH224620H, and BWH224623H. The devices have been distributed nationwide and worldwide.

Patients with these devices should contact their healthcare provider immediately. Your cardiologist can verify whether your device is part of this recall and discuss appropriate next steps.

The recalled product

Product: ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable cardiac devices
Hazard: therapy-failure
device-malfunction
defibrillation-failure
Affected units: 4

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 (5)

GTIN 00643169720435
Lot Serial Number: BWH224619H
BWH224621H
BWH224620H
BWH224623H

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
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Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
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Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
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Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · therapy failure