Agency classClass IOur severity:Severe FDA (Devices)·Z-1710-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy

Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.

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 mandates a minimum severity score of 4. Although no illnesses or injuries are reported in the source text, the potential for therapy failure in life-sustaining implantable devices warrants severe classification.

Plain-English summary

Medtronic Inc. is recalling certain model DDBC3D4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a manufacturing defect. The affected devices may experience reduced or no energy output during high-voltage therapy delivery, typically in the 0 to 12-joule range.

The issue stems from a defect in the device's feedthrough component. In rare cases, this defect may result in insufficient energy delivery during critical therapy events, potentially compromising the device's life-saving function.

The recall affects approximately 4,056 units distributed nationwide and internationally. Patients with affected devices are identifiable by specific lot serial numbers listed in the FDA recall notice.

Patients with affected ICDs or CRT-Ds should contact their healthcare provider or Medtronic to determine if their device is affected. Patients should maintain regular monitoring and follow-up appointments with their cardiologist.

The recalled product

Product: ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Devices
Hazard: device-malfunction
therapy-failure
Affected units: 4,056

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 00643169720381
Lot Serial Numbers: BWF206541H
BWF206448H
BWF206403H
BWF206382H
BWF206552H
BWF206320H
BWF206323H
BWF206420H
BWF206376H
BWF206458H
BWF206459H
BWF206430H
BWF206453H
BWF206359H
BWF206478H
BWF206333H
BWF206365H
BWF206370H
BWF206557H

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 →

Severe
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 · device malfunction