Agency classClass IOur severity:Severe FDA (Devices)·Z-1759-2023·Announced 2023-06-28

Implantable Cardiac Defibrillators May Fail During High-Voltage Therapy

Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.

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 requires a minimum severity rating of 4. Although no illnesses or injuries have been reported and the hazard is described as rare, the potential for reduced or complete failure of high-voltage therapy in implantable cardiac defibrillators—devices critical for preventing sudden cardiac death—justifies this severe rating.

Plain-English summary

The recall affects implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific type of glassed feedthrough component. The defect creates a rare potential for reduced or no-energy output during high-voltage therapy, typically at dose levels of 0-12 joules.

The affected devices include the CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1 model. A total of 1,658 units have been identified as potentially affected. These devices are distributed in the United States and worldwide.

The defective feedthrough component may cause therapy failure when the device needs to deliver high-voltage treatment. Patients with affected devices should contact their healthcare provider or Medtronic immediately. No illnesses or injuries have been reported at this time.

The recalled product

Product: CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Defibrillators
Hazard: reduced-energy-output
device-malfunction
Affected units: 1,658

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 00643169837614
Lot Serial numbers: RPN602297S
RPN602079S
RPN601385S
RPN601320S
RPN601216S
RPN601977S
RPN602107S
RPN600885S
RPN601199S
RPN600682S
RPN601504S
RPN601513S
RPN601653S
RPN601681S
RPN602258S
RPN600961S
RPN600858S
RPN600867S
RPN600868S

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 · reduced energy output