Agency classClass IOur severity:Critical FDA (Devices)·Z-1769-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure

Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, the most serious regulatory classification for medical devices. FDA Class I is designated for devices that could cause serious adverse health consequences or death. In this case, a manufacturing defect could prevent life-critical defibrillation therapy delivery.

Plain-English summary

Medtronic Inc. is recalling CRTD DTMC1D1 COMPIA MRI US DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). A total of 664 units with specific lot serial numbers manufactured with a particular feedthrough component are affected.

There is a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically at the 0-12 joule level. This defect could prevent the device from delivering adequate therapeutic energy during critical defibrillation therapy.

The affected devices were distributed in the United States and internationally. Patients with implanted devices from the recalled lot numbers should check their device information and contact their healthcare provider or Medtronic for guidance regarding evaluation or replacement.

The recalled product

Product: CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device
Hazard: therapy-delivery-failure
electrical-malfunction
device-defect
Affected units: 664

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 00643169837706
Lot Serial Numbers: RPW200770H
RPW200730H
RPW201054H
RPW200583H
RPW200593H
RPW200970H
RPW201002H
RPW201095H
RPW200917H
RPW201040H
RPW201026H
RPW200661H
RPW200981H
RPW200665H
RPW200741H
RPW200743H
RPW200908H
RPW200971H
RPW200600H

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 delivery failure