Medtronic TurboHawk Plus Directional Atherectomy System recall
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Why was Medtronic TurboHawk Plus Directional Atherectomy System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00763000402419
- Product
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
- Recalling firm
- ev3 Inc.
- Quantity
- 245 devices
- Distribution
- 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.
- Recall date
- March 16, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)