Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00763000402396
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ev3 Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Product Codes/Lot Numbers:
GTIN 00763000402396
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0694-2022
Related Recalls
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
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.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.