Agency classClass IOur severity:Severe FDA (Devices)·Z-1731-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure

Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.

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 designation mandates a minimum severity rating of 4. The recalled implantable defibrillators pose a risk of therapeutic failure in life-threatening cardiac situations. Although no illnesses or injuries are explicitly reported in the source, the potential for device failure to deliver life-saving therapy is inherently serious.

Plain-English summary

Medtronic, Inc. is recalling 661 CRT-D (cardiac resynchronization therapy defibrillator) devices, Model DTBA1D4 VIVA XT IS1/DF4 US. These are implantable cardioverter defibrillators designed to monitor heart rhythm and deliver electrical therapy when dangerous arrhythmias occur.

The recall addresses a rare manufacturing defect in a specific feedthrough component. This defect may result in reduced or no energy output during high-voltage therapy (typically 0–12 joules). The affected devices were distributed nationwide in the United States and worldwide.

Patients with these devices are at risk if dangerous cardiac arrhythmias occur and the device fails to deliver necessary electrical treatment. The FDA classified this as a Class I recall. Patients should contact their healthcare provider to determine if their device is affected.

The recalled product

Product: CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: therapeutic-failure
energy-output-failure
Affected units: 661

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 00643169720251
Lot Serial Numbers: BLE221424H
BLE221443H
BLE221244H
BLE221357H
BLE221415H
BLE221487H
BLE221190H
BLE221267H
BLE221842H
BLE221265H
BLE221430H
BLE221711H
BLE221346H
BLE221631H
BLE221285H
BLE221405H
BLE221436H
BLE221551H
BLE221411H

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 · therapeutic failure