Agency classClass IOur severity:Severe FDA (Devices)·Z-1705-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy

Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.

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: This is an FDA Class I recall, which per the rubric requires a minimum severity score of 4 (Severe). The defect affects critical therapy delivery in life-saving cardiac devices. Although no illnesses or deaths have been reported, the potential for device failure during therapy represents serious risk.

Plain-English summary

Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDBB1D4 (EVERA XT IS1/DF4 US). A total of 522 units manufactured with a specific feedthrough component have been identified in this recall.

The defect presents a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12 joules). This issue stems from the specific feedthrough component used in the affected devices. The FDA has classified this as a Class I recall.

The affected devices have been distributed nationwide in the United States and worldwide. Multiple lot serial numbers are associated with the recalled units.

The recalled product

Product: ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Defibrillators
Hazard: device-malfunction
therapy-failure
Affected units: 522

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 00643169720374
Lot Serial Numbers: BWB231977H
BWB232204H
BWB231981H
BWB231888H
BWB232232H
BWB232076H
BWB231876H
BWB231908H
BWB231979H
BWB232244H
BWB232310H
BWB231918H
BWB232114H
BWB231867H
BWB232361H
BWB231879H
BWB231847H
BWB232311H
BWB232048H

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 · device malfunction