Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.
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: This is an FDA Class I recall, which establishes a minimum severity score of 4 per the rubric. While no adverse events are explicitly reported for this specific device, the potential for tip detachment and embolization in peripheral vasculature represents serious patient safety risk.
Plain-English summary
The Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel (catalog number THP-S) is being recalled. Manufactured by ev3 Inc., this device is used for atherectomy procedures in peripheral blood vessels.
The recall was issued as a Class I recall because the device shares design similarities with another system that experienced instances of tip detachment and embolization. The design similarities raise concern that this device could experience the same failure mode.
The recall affects 245 devices distributed nationwide to healthcare facilities across multiple states including Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, South Dakota, Tennessee, Texas, and Virginia.
Patients and healthcare providers should contact Medtronic or ev3 Inc. for guidance on affected devices. Healthcare facilities with affected devices (catalog number THP-S, GTIN 00763000402419) should follow manufacturer instructions for handling and replacement.
The recalled product
- Product
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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 00763000402419
Distribution
Distributed nationwide across the United States.
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