ICD defibrillators risk reduced or absent therapy output from feedthrough defect
Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and 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 mandates a minimum severity score of 4. Although no illnesses or deaths are reported, the potential for therapy failure in a life-critical implanted cardiac device represents a serious safety risk.
Plain-English summary
The FDA has issued a Class I recall of ICD CROME VR MRI DF4 implantable cardioverter defibrillators (Model Number DVPC3D4) manufactured by Medtronic Inc. These devices contain a feedthrough component that may result in reduced or no energy output during high-voltage therapy (typically 0-12 joules). Approximately 2,031 units are affected, with distribution in the United States and worldwide.
The potential for reduced or absent energy output during cardiac defibrillation therapy is a serious safety concern. These devices are implanted to treat life-threatening heart rhythm disturbances, and failure to deliver adequate defibrillation energy when needed could prevent appropriate treatment of dangerous cardiac events.
Patients implanted with an ICD CROME VR MRI DF4 should verify with their healthcare provider whether their device is subject to this recall based on the product lot serial number.
The recalled product
- Product
- ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-failure
- energy-output-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 00763000178550. Lot Serial Numbers: RSH600068S
- RSH600173S
- RSH600239S
- RSH601126S
- RSH601127S
- RSH601883S
- RSH601888S
- RSH601444S
- RSH601463S
- RSH601537S
- RSH601538S
- RSH600064S
- RSH600099S
- RSH600174S
- RSH600175S
- RSH600228S
- RSH600275S
- RSH600276S
- RSH600889S
- RSH600903S
Distribution
Distributed nationwide across the United States.
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