Implantable defibrillators may deliver reduced or no energy during therapy
Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.
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 classification for implantable medical devices indicates serious potential health risk. The potential for reduced or absent energy output in a life-critical defibrillation device represents significant hazard.
Plain-English summary
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific type of glassed feedthrough component. Approximately 8,575 units have been distributed nationwide and worldwide.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12 joules). This defect in the feedthrough component may prevent proper delivery of defibrillation therapy.
Patients with these devices should contact their healthcare provider or Medtronic to determine if their specific device is affected and obtain guidance on recommended actions.
The recalled product
- Product
- CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
- feedthrough-defect
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 00643169720725
- Lot Serial Numbers: RPK603310S
- RPK606030S
- RPK607323S
- RPK606692S
- RPK605552S
- RPK604274S
- RPK607156S
- RPK607510S
- RPK606721S
- RPK606379S
- RPK606753S
- RPK603895S
- RPK607997S
- RPK608001S
- RPK608115S
- RPK602608S
- RPK602842S
- RPK602915S
- RPK603155S
Distribution
Distributed nationwide across the United States.
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