CLASS I Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled

ev3 is recalling Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, distributed nationwide in the US. The recall was initiated on 4 Feb 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 00763000402396

Quantity recalled441 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0694-2022
FDA event ID: 89470
Recalling firm: ev3, Plymouth, MN
Classification: Class I
Status: Terminated
Recall initiated: 4 Feb 2022
FDA classified: 7 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Feb 2022	Recall initiated by company
7 Mar 2022	Classified by FDA	+31 days
16 Mar 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

Where it was distributed

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.

Nationwide Arizona California Florida Iowa Illinois Kansas Louisiana Michigan Mississippi North Carolina New Jersey New York Oregon South Carolina South Dakota Tennessee Texas Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

GTIN 00763000402396

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89470

This product is part of a recall event; the main page for the event is Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled.

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022	CLASS I	Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled	ev3	Other	Nationwide

More recalls from ev3

All 11

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Medtronic NanoCross Elite PTA catheter recalled by ev3	ev3	Other	Nationwide
16 Mar 2022Device	CLASS I	Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled	ev3	Other	Nationwide
26 Jan 2022Device	CLASS I	Medtronic HawkOne Directional Atherectomy System recalled by ev3	ev3	Other	Nationwide
26 Jan 2022Device	CLASS I	Medtronic HawkOne Directional Atherectomy System recalled by ev3	ev3	Other	Nationwide
7 Oct 2020Device	CLASS II	Pacific Xtreme (PTCA Balloon Dilation Catheter) recalled by ev3	ev3	Other	42 states

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