Agency classClass IOur severity:Severe FDA (Devices)·Z-1711-2023·Announced 2023-06-28

Medtronic Cardiac Defibrillators May Fail to Deliver Therapy

Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.

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 on implanted cardiac devices with potential for therapy failure. Although no illnesses or injuries have been reported, the hazard classification reflects the serious nature of potential malfunction in a life-critical medical device.

Plain-English summary

Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DDMB1D1, manufactured with a specific feedthrough component may produce reduced or no energy output during high voltage (HV) therapy, typically in the 0–12 joules range. This is a rare potential defect affecting devices currently implanted in patients.

Approximately 22,484 units of the affected model have been distributed nationwide and worldwide. Patients who have received these devices should contact their healthcare provider to determine if their device is affected and to discuss appropriate management options.

The FDA has issued a Class I recall for this defect. Patients should not discontinue use of their devices without consulting their healthcare provider.

The recalled product

Product: ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Cardiac Defibrillator
Hazard: reduced-energy-output
therapy-failure
Affected units: 22,484

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 00643169837713
Lot Serial Numbers: CWA218162H
CWA219897H
CWA221224H
CWA222730H
CWA223319H
CWA224001H
CWA230660H
CWA212204H
CWA215507H
CWA219655H
CWA228049H
CWA228101H
CWA230635H
CWA230642H
CWA213967H
CWA217145H
CWA220168H
CWA225093H
CWA229346H

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 · reduced energy output