Agency classClass IOur severity:Severe FDA (Devices)·Z-1768-2023·Announced 2023-06-28

Medtronic Implantable Defibrillators Risk Failure to Deliver High-Voltage Therapy

Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.

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 represents a direct threat to public health. Although no illnesses or injuries have been reported, the potential for reduced or no-energy output in a critical life-support device justifies this regulatory urgency and severity level.

Plain-English summary

Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTMB2QQ, manufactured with a specific glassed feedthrough design. The recall affects 28,172 units distributed worldwide.

These devices carry a rare potential for reduced or no-energy output during high-voltage therapy (typically 0-12 joules). This malfunction could prevent the device from delivering therapy when needed, which is critical for patients depending on these devices for cardiac rhythm management.

If you have received one of the affected devices, contact your healthcare provider to determine if your device is subject to this recall. Do not discontinue use without medical guidance. Patients should discuss this recall with their healthcare provider for further guidance.

The recalled product

Product: CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: reduced-energy-output
therapy-failure
Affected units: 28,172

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 00643169720695
Lot Serial numbers: RPG619037S
RPG608482S
RPG611787S
RPG619305S
RPG609628S
RPG622247S
RPG619130S
RPG623603S
RPG610818S
RPG616992S
RPG619816S
RPG624535S
RPG614089S
RPG619704S
RPG619714S
RPG623002S
RPG624602S
RPG607260S
RPG607434S

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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Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
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Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
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Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · reduced energy output