Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral va
FDA device recall Z-0695-2022 · posted 2022-03-07 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 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.
- Date initiated
- 2022-02-04
- Date posted
- 2022-03-07
- Date terminated
- 2024-10-02
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TurboHawk Plus Directional Atherectomy System (K212027) | Medtronic, Inc. | 2021-08-24 |