Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. The rule states FDA Class I recalls never score below 4. The device may fail to deliver critical high-voltage therapy, compromising treatment effectiveness. No illnesses or injuries have been reported.
Plain-English summary
The FDA is recalling certain Medtronic CRTD DTMA1D1 CLARIA MRI implantable cardioverter defibrillators and related ICDs due to a potential defect in the high-voltage feedthrough. These devices may produce reduced or no energy output during high-voltage therapy delivery, typically in the 0-12 joule range, which could prevent proper treatment in patients dependent on the device.
The defect affects implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators manufactured with a specific glassed feedthrough component. Approximately 11,794 units are affected, with distribution across the United States and worldwide.
Patients with affected devices should contact their healthcare provider or Medtronic to determine if their specific device is included in this recall. Healthcare providers should review patient records to identify affected devices and discuss appropriate management options with each patient.
The recalled product
- Product
- CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-failure
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 00643169837676
- Lot Serial Numbers: RPT208454H
- RPT211000H
- RPT208258H
- RPT211071H
- RPT211077H
- RPT210886H
- RPT209224H
- RPT211338H
- RPT211343H
- RPT211344H
- RPT211347H
- RPT208864H
- RPT210392H
- RPT204063H
- RPT207540H
- RPT210779H
- RPT211477H
- RPT210662H
- RPT203810H
Distribution
Distributed nationwide across the United States.
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