TurboHawk Plus recallZ-0695-2022 · ev3 Inc. · initiated Feb 4, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ev3 Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0695-2022
- Status
- Terminated
- Initiated by the company
- Feb 4, 2022
- Posted by the FDA
- Mar 7, 2022
- Recalling firm
- ev3 Inc.
- Quantity
- 245 devices
- Product code
- MCW
- FDA submissions
- K212027
- 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.
Product description
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Code information (models, lots, serial numbers)
GTIN 00763000402419
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TurboHawk™ Plus THP-SMedtronic, Inc. · Catheter, peripheral, atherectomy1 recall6 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K212027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TurboHawk™ Plus THP-MMedtronic, Inc. · Catheter, peripheral, atherectomy1 recall65 reports
- TurboHawk™ Plus THP-LXMedtronic, Inc. · Catheter, peripheral, atherectomy7 reports
- TurboHawk™ Plus THP-LSMedtronic, Inc. · Catheter, peripheral, atherectomy4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 89470).
- Z-0694-2022 · TerminatedMedtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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