Agency classClass IOur severity:Severe FDA (Devices)·Z-1794-2023·Announced 2023-06-28

FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk

Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.

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 designation. Guidance requires that FDA Class I recalls receive a minimum severity score of 4. Although no incidents have been reported, the potential for reduced or absent energy output during high-voltage therapy in implantable cardioverter defibrillators justifies the Severe classification.

Plain-English summary

Medtronic Inc. has recalled certain ICD-VR VISIA AF S US/OUS DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall is due to a potential defect in the high-voltage feedthrough component used in these devices. The issue affects both devices currently implanted and those available in inventory.

The affected devices may experience reduced or no energy output during high-voltage therapy, typically 0-12 joules. This issue stems from a specific glassed feedthrough used in the manufacturing process.

A total of 194 units with this defect have been identified and distributed nationally and worldwide. Specific lot serial numbers associated with this recall have been identified by the manufacturer and are available from the FDA.

The recalled product

Product: ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: output-failure
device-malfunction
Affected units: 194

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 00643169720787
Lot Serial Numbers: BWV600051S
BWV600052S
BWV600078S
BWV600079S
BWV600010S
BWV600094S
BWV600024S
BWV600027S
BWV600031S
BWV600032S
BWV600041S
BWV600042S
BWV600043S
BWV600044S
BWV600045S
BWV600046S
BWV600047S
BWV600068S
BWV600069S

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
Severe
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 · output failure