Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
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 requires a minimum severity score of 4 per the rubric. The source does not report any actual illnesses or injuries with the TurboHawk Plus itself, only design similarity to a device that experienced embolization incidents.
Plain-English summary
The device being recalled is the Medtronic TurboHawk Plus Directional Atherectomy System 6F (Catalog number THP-M), a medical device used in peripheral vascular procedures. Approximately 441 devices have been distributed nationwide.
The recall was initiated due to design similarities with another directional atherectomy system for which the manufacturer recently issued a field correction. That other device had reported instances of tip detachment and embolization. Because of the design similarities, there is a potential risk that the TurboHawk Plus could experience similar complications.
The affected devices were distributed to medical facilities in Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, South Dakota, Tennessee, Texas, and Virginia. Healthcare providers and patients should contact the manufacturer for guidance on whether the device requires removal, replacement, or monitoring.
The recalled product
- Product
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
- Manufacturer
- ev3 Inc.
- Hazard
- tip-detachment
- embolization
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 (1)
- GTIN 00763000402396
Distribution
Distributed nationwide across the United States.
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