Agency classClass IOur severity:Severe FDA (Devices)·Z-1713-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy

Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.

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 establishes a minimum severity of 4 per the rubric. Although no deaths or illnesses have been reported, the potential consequence—failure of a life-critical cardiac device to deliver defibrillation therapy—is serious. Class I designation reflects the FDA's determination that the defect poses a serious risk to health.

Plain-English summary

Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDMB2D1 EVERA MRI XT OUS DF1. The recall affects 8,626 units distributed nationwide and worldwide. These devices were manufactured with a specific feedthrough.

There is a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range. If such a failure occurs, the device would be unable to deliver the defibrillation therapy necessary to treat dangerous heart rhythms.

Patients with affected devices should contact their healthcare provider or Medtronic. Information to identify affected devices, including specific lot serial numbers, is available through the manufacturer and the FDA.

The recalled product

Product: ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: reduced-energy-output
therapy-failure
Affected units: 8,626

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 00643169837720
Lot Serial Numbers: CWB609778S
CWB609784S
CWB609523S
CWB603432S
CWB605718S
CWB601752S
CWB601945S
CWB601946S
CWB602803S
CWB605225S
CWB607387S
CWB609714S
CWB605552S
CWB601729S
CWB602371S
CWB603105S
CWB603660S
CWB603852S
CWB604726S

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
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · reduced energy output