FDA Medical Device Recalls (openFDA)
ev3 Inc.: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
- Recall number
- Z-0695-2022
- Recalling firm
- ev3 Inc.
- Product
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
- Status
- Terminated
- Initiated
- 2022-02-04
- Posted
- 2022-03-07
- Terminated
- 2024-10-02
- Reason
- 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.
- Root cause
- Labeling design
- Action
- The recalling firm began issuing the URGENT MEDICAL DEVICE NOTICE dated February 2022 on 2/4/2022 via 2-day UPS delivery. The letter explained the issue and instructed the consignee to adhere to the existing IFU instructions and warnings and precautions listed in the letter to reduce the risk of guidewire prolapse. The Customer Instructions included the notice was to be shared with all who needed to be aware within the consignee's organization or to any other organization where the product has been transferred; to review the IFU included with the product prior to use, noting the warnings and precautions listed in the notice; and to complete the Customer Confirmation Form to acknowledge receipt of the notice and that the appropriate action has been taken. It was to be emailed to the recalling firm.
- 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.
- Lot, serial or model codes
- GTIN 00763000402419
- 510(k) numbers
- ["K212027"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 2183870
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28