Severe FDA (Devices)·Z-1744-2023·Announced 2023-06-28

Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure

Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this recall as Class I, establishing a minimum severity of 4 per the rubric. Although no deaths or serious injuries have been reported, the potential for defibrillation therapy failure in a life-critical implantable cardioverter warrants a Severe rating.

Plain-English summary

Medtronic is recalling CRT-D VIVA QUAD S IS4/DF4 implantable cardioverter defibrillators (model DTBB1QQ). These devices are implanted in patients' chests to monitor heart rhythm and deliver electrical therapy when abnormal heartbeats are detected. The recall involves 193 units distributed nationwide in the US and worldwide.

Affected devices may have a rare defect in the glassed feedthrough component that could cause reduced or no energy output during high-voltage defibrillation therapy (typically 0-12 joules). This means the device might fail to deliver the necessary electrical shock when needed to correct dangerous heart rhythms.

All recalled devices are identified by specific lot serial numbers, including BLK205268H, BLK205272H, BLK205461H, and 190 additional lot numbers listed in the FDA recall notice (Z-1744-2023). Patients should check with their healthcare provider to determine if their implanted device is affected.

If you have an implanted device from an affected lot number, contact your cardiologist or healthcare provider immediately. Your medical team can determine whether your device is affected and discuss appropriate next steps based on your individual medical condition.

The recalled product

Product: CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Defibrillator
Hazard: therapy-failure
device-malfunction
Affected units: 193

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 00643169720145
Lot Serial Numbers: BLK205268H
BLK205272H
BLK205461H
BLK205544H
BLK205582H
BLK205328H
BLK205358H
BLK205475H
BLK205492H
BLK205304H
BLK205346H
BLK205364H
BLK205269H
BLK205352H
BLK205349H
BLK205400H
BLK205432H
BLK205451H
BLK205309H

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 →

Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28

Same hazard · therapy failure