Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the most serious regulatory classification for medical devices. FDA Class I is designated for devices that could cause serious adverse health consequences or death. In this case, a manufacturing defect could prevent life-critical defibrillation therapy delivery.
Plain-English summary
Medtronic Inc. is recalling CRTD DTMC1D1 COMPIA MRI US DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). A total of 664 units with specific lot serial numbers manufactured with a particular feedthrough component are affected.
There is a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically at the 0-12 joule level. This defect could prevent the device from delivering adequate therapeutic energy during critical defibrillation therapy.
The affected devices were distributed in the United States and internationally. Patients with implanted devices from the recalled lot numbers should check their device information and contact their healthcare provider or Medtronic for guidance regarding evaluation or replacement.
The recalled product
- Product
- CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Category
- Medical Device
- Hazard
- therapy-delivery-failure
- electrical-malfunction
- device-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 00643169837706
- Lot Serial Numbers: RPW200770H
- RPW200730H
- RPW201054H
- RPW200583H
- RPW200593H
- RPW200970H
- RPW201002H
- RPW201095H
- RPW200917H
- RPW201040H
- RPW201026H
- RPW200661H
- RPW200981H
- RPW200665H
- RPW200741H
- RPW200743H
- RPW200908H
- RPW200971H
- RPW200600H
Distribution
Distributed nationwide across the United States.
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