Agency classClass IOur severity:Severe FDA (Devices)·Z-1770-2023·Announced 2023-06-28

Cardioverter Defibrillators Recalled: Potential Reduced or No-Energy Output

Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.

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 FDA Class I recall requires a minimum Severe rating per the FDA classification rule. The potential for therapy failure in life-critical situations, combined with FDA Class I designation, justifies the Severe rating despite no reported injuries to date.

Plain-English summary

Medtronic has issued a Class I recall for certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The defect involves a specific type of feedthrough component that can affect therapy delivery.

The potential for reduced or no-energy output during high-voltage therapy poses a serious risk to patients who depend on their devices for cardiac protection. Although no injuries or deaths have been reported to date, the condition could prevent proper defibrillation when needed.

Patients with affected devices should contact Medtronic immediately. The company has provided a list of affected lot serial numbers spanning both US and worldwide distribution. Healthcare providers should work with patients to determine if their devices are affected and discuss appropriate management options.

The recalled product

Product: CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: reduced-energy-output
therapy-failure

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 00643169720749
Lot Serial Numbers: RPL202320H
RPL202797H
RPL202825H
RPL203304H
RPL203279H
RPL203319H
RPL203730H
RPL203754H
RPL204075H
RPL202479H
RPL202565H
RPL202842H
RPL203342H
RPL203518H
RPL203521H
RPL203522H
RPL203534H
RPL203543H
RPL203556H

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 · reduced energy output