Agency classClass IOur severity:Severe FDA (Devices)·Z-1790-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a glassed feedthrough defect. The FDA Class I recall involves 240 units.

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 medical device recalls require a minimum severity score of 4 (Severe) per the rubric. The hazard involves potential failure of therapy delivery in a life-critical device; however, the source reports no deaths or confirmed injuries, so the score remains 4 rather than 5 (Critical).

Plain-English summary

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically the ICD-VR DVAB1D4 VISIA AF US DF4 model. These are implanted devices designed to deliver electrical therapy to correct dangerous heart rhythms.

The recalled devices may produce reduced or no energy output during high-voltage therapy (typically 0-12 joules) due to a defect in a specific glassed feedthrough component. This creates a rare potential for the device to fail to deliver the necessary electrical therapy.

The recall affects 240 units distributed nationwide in the United States and worldwide. Affected devices are identified by specific lot serial numbers.

The FDA classified this as a Class I recall due to the serious potential for therapy failure in a life-critical device. Patients with this device model should contact their healthcare provider or Medtronic to verify whether their device is affected.

The recalled product

Product: ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Defibrillator
Hazard: therapy-failure
device-malfunction
Affected units: 240

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 00643169720626
Lot Serial Numbers: BWP202537H
BWP202379H
BWP202439H
BWP202454H
BWP202474H
BWP202510H
BWP202522H
BWP202523H
BWP202252H
BWP202639H
BWP202514H
BWP202179H
BWP202398H
BWP202399H
BWP202554H
BWP202420H
BWP202447H
BWP202494H
BWP201863H

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