Agency classClass IOur severity:Severe FDA (Devices)·Z-1797-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output

Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.

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 recall. Although no illnesses or injuries have been reported, the potential for reduced or no energy output in implanted cardiac defibrillators during high voltage therapy could prevent necessary treatment in patients with life-threatening arrhythmias.

Plain-English summary

Medtronic Inc. has recalled certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. The affected model is the ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, with approximately 1,354 units involved in the recall.

There is a rare potential for these devices to produce reduced or no energy output during high voltage (0-12 joule) therapy. This could prevent the device from delivering necessary treatment when patients require life-saving defibrillation.

The recalled devices were distributed in the United States and internationally. Patients implanted with one of the potentially affected devices can consult the official FDA recall notice for the complete list of affected serial numbers and can contact their healthcare provider for evaluation.

The recalled product

Product: ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Defibrillator
Hazard: device-malfunction
therapy-failure
Affected units: 1,354

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 00643169218017
Lot Serial numbers: BWK607537S
BWK607358S
BWK607401S
BWK607460S
BWK607496S
BWK607540S
BWK607351S
BWK607371S
BWK607254S
BWK607394S
BWK607446S
BWK607457S
BWK607473S
BWK607498S
BWK607503S
BWK607536S
BWK607381S
BWK607393S
BWK607369S

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
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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 · device malfunction