Z-0695-2022Class I

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in...

Name: Z-0695-2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in...
Creator: ev3 Inc.
Published: 2022-02-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-02-04 / Terminated / root cause: labeling and UDI

FDA source

ev3 Inc. began a recall of Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature on 2022-02-04. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0695-2022
Classification: Class I
Status: Terminated
Initiated: 2022-02-04
Posted: 2022-03-07
Terminated: 2024-10-02
Recalling firm: Medtronic, Inc.
Product: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: GTIN 00763000402419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2022	Class I	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-07
Z-0695-2022	Class I	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-07

Product code MCW

K212027Class IITurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. / cleared 2021-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)