Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect

Plain-English summary

Medtronic is recalling approximately 8,602 units of the CRTD DTMA1Q1 CLARIA MRI QUAD US DF1 model implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The devices were manufactured with a specific glassed feedthrough component that can result in rare instances of reduced or absent energy output during high-voltage therapy delivery.

Implantable cardioverter defibrillators and CRT-Ds are critical life-saving devices designed to monitor heart rhythm and deliver electrical therapy to prevent sudden cardiac death. When functioning properly, these devices provide essential treatment for dangerous heart rhythms. A failure to deliver adequate therapy energy represents a serious functional defect that could prevent life-saving treatment.

Affected devices have been distributed in the United States and worldwide. Patients should not discontinue use of their devices without consulting their healthcare provider, as removal of a functioning ICD poses greater health risk. Patients with these devices should contact their physician or Medtronic to determine if their device is affected based on the lot serial numbers provided in the recall notice.

The recalled product

Product

CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators

Manufacturer

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

Category

Medical Device — Implantable Cardiovascular Devices

Hazard

• device-malfunction
• therapy-failure
• energy-output-failure

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.

Related recalls