Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

Plain-English summary

Medtronic Inc. is recalling the ICD-DR DDME3D1 MIRRO MRI implantable cardioverter defibrillators (ICDs) and certain cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. Approximately 2,831 units have been distributed nationwide and worldwide. These devices are identified by GTIN 00763000001568 and a large number of specific lot serial numbers (CWS600097S through CWS603267S).

There is a rare potential for reduced or no-energy output during high-voltage therapy, typically 0-12 joules. This defect could compromise the device's ability to deliver appropriate defibrillation therapy during cardiac arrhythmia events when such therapy is critical.

Patients with affected devices should contact their cardiologist or Medtronic immediately to determine whether their specific device is included in this recall. Healthcare providers should review implant records and patient identifiers to identify affected devices. Patients should not discontinue device use without medical guidance and should consult their healthcare provider for assessment and discussion of management or replacement options.

The recalled product

Product

ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators

Manufacturer

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

Category

Medical Device — Implantable cardiac defibrillator

Hazard

• therapy-failure
• device-malfunction
• 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.

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