Agency classClass IOur severity:Severe FDA (Devices)·Z-1708-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators with defective feedthrough may fail therapy delivery

Medtronic's EVERA XT implantable cardioverter defibrillators may fail to deliver therapy due to a rare feedthrough defect affecting 727 units 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 classification requires minimum severity 4. Although no illnesses or deaths have been reported and the hazard is rare and potential, the device is life-critical and directly impacts cardiac function delivery.

Plain-English summary

Medtronic Inc. is recalling 727 units of the EVERA XT implantable cardioverter defibrillators (ICDs) with model number DDBB2D4. The devices contain a specific defective feedthrough component that could lead to reduced or no energy output during high voltage therapy delivery.

The recall involves ICDs manufactured with a glassed feedthrough defect. This defect creates a rare potential for the device to fail in delivering critical high voltage therapy (typically 0-12J) for heart rhythm management.

The affected devices have been distributed nationwide and worldwide. Patients with affected devices should contact Medtronic or their healthcare provider immediately. Healthcare providers can reference the specific lot serial numbers and product codes provided in the FDA recall notice to determine if they have affected devices.

The recalled product

Product: ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: therapy-failure
device-malfunction
Affected units: 727

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 00643169217928
Lot Serial Numbers: BWD609356S
BWD609450S
BWD609318S
BWD609387S
BWD609454S
BWD609558S
BWD609464S
BWD609549S
BWD609355S
BWD609467S
BWD609389S
BWD609343S
BWD609397S
BWD609567S
BWD609395S
BWD609462S
BWD609470S
BWD609316S
BWD609554S

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
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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 · therapy failure