Implantable Defibrillators May Fail to Deliver Critical Therapy

Plain-English summary

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMC2QQ COMPIA MRI QUAD OUS DF4. The devices were manufactured with a specific feedthrough component and have been distributed nationwide in the United States and internationally.

The affected devices present a rare potential for reduced or no-energy output during high-voltage (HV) therapy delivery, typically at dose levels of 0-12 joules. High-voltage therapy provides the defibrillation function necessary to treat dangerous cardiac arrhythmias. Inadequate or absent energy output could prevent the device from delivering this critical therapy.

Approximately 31,884 units are affected by this FDA Class I recall. The FDA's Class I classification indicates the most serious category of recall due to potential for serious adverse health consequences. Affected devices are identified through specific lot serial numbers.

Patients with implanted devices should identify their device serial number and verify whether it appears on the recall list provided by Medtronic. Healthcare providers should check affected serial numbers for their patients and follow Medtronic's guidance for appropriate device management.

The recalled product

Product

CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Category

Medical Device — Implantable Defibrillators

Hazard

• defibrillation-failure
• device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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