FDAFDA · Food and drugs·Recall number Z-0695-2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Published March 16, 2022 · Recall initiated: February 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ev3 Inc.
- Distributor
- US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
- Lot
- GTIN 00763000402419
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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