Agency classClass IOur severity:Severe FDA (Devices)·Z-1720-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy

Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected 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: This is an FDA Class I recall of a critical cardiac device. Per the severity rubric, FDA Class I recalls must never be scored below 4. Although the source describes the defect as a "rare potential" with no reported illnesses or injuries, the device's critical function in treating life-threatening heart rhythms and the potential for complete therapy failure justify the agency's Class I classification.

Plain-English summary

Medtronic has issued a Class I recall for specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDME3D4. These devices are implanted in patients with serious heart rhythm disorders to detect and treat life-threatening arrhythmias.

The recall addresses a rare potential defect in devices manufactured with a specific glassed feedthrough component. Affected devices may produce reduced or no energy output during high voltage therapy (typically 0-12J). Because these devices are essential for treating potentially fatal heart rhythms, any failure to deliver therapy poses a serious health risk.

Approximately 8,219 units were distributed to patients nationwide and worldwide. Medtronic has identified specific lot serial numbers associated with the defect.

The recalled product

Product: ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: therapy-failure
reduced-energy-output
Affected units: 8,219

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 00763000001582
Lot Serial Numbers: CWT605432S
CWT600264S
CWT607420S
CWT607213S
CWT607463S
CWT607388S
CWT607425S
CWT607374S
CWT607359S
CWT601622S
CWT603529S
CWT605876S
CWT605723S
CWT604657S
CWT604666S
CWT605105S
CWT605034S
CWT608381S
CWT608194S

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
FDA (Devices) · 2023-06-28
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Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
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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 failure