Use cautionMedical device recall · FDA · Published February 4, 2022
ev3 TurboHawk Plus Atherectomy System Recall: Tip Detachment Risk
Medtronic recalls its TurboHawk Plus 6F directional atherectomy system for small vessel use due to tip detachment risk. Affected units have catalog number THP-S and GTIN 007630:00402419.
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.
Take action
Contact the company
📍Recalling firmev3 Inc.4600 Nathan Ln N · Plymouth, MN 55442-2890
✎ GovInfoNow plain-language explainer
Medtronic is recalling its TurboHawk Plus Directional Atherectomy System 6F for small vessels because it has design similarities to a device that caused tip detachment and embolization. This could lead to serious complications if the device malfunctions during use. Read more at govinfonow.com/recall/61178-ev3-turbohawk-plus-atherectomy-system-recall-tip-detachment-risk.
“ev3 TurboHawk Plus Atherectomy System Recall: Tip Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61178-ev3-turbohawk-plus-atherectomy-system-recall-tip-detachment-risk. Based on FDA recall #Z-0695-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0695-2022%22&limit=1).
The FDA announced on Feb. 4, 2022, that ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to potential tip detachment and embolization risks. This voluntary Class I recall affects 245 devices distributed nationwide.
How to tell if you have it
Brand: ev3
Product: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel
Catalog number: THP-S
UPC: 00763000402419
GTIN: 00763000402419
The hazard
According to the FDA, the device has design similarities to another device that required a field correction due to instances of tip detachment and embolization. The recall addresses these specific safety concerns.
Context
GovInfoNow's records show ev3 Inc. has 3 other recalls on record since Aug. 26, 2020. Other recent recalls of similar products include Medtronic NanoCross Elite PTA Catheter Recall (Dec. 10, 2024), Medtronic HawkOne Directional Atherectomy System Recall (Dec. 6, 2021), and ev3 Pacific Xtreme Balloon Catheter Recall (Aug. 26, 2020). Additional similar product recalls include Medtronic Harmony Catheter System Recall (May 22, 2026), Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026), and Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026).
How to tell if you have this one
Check for the catalog number THP-S on the device packaging or label. The product was sold with GTIN 00763000402419 for peripheral vascular procedures.
Brand
ev3
Product
ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0694-2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.; GTIN 00763000402396
441 devices
Z-0695-2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.; GTIN 00763000402419
245 devices
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for the catalog number THP-S on the device packaging or label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Iowa, Kansas, Louisiana, Michigan, Mississippi, New Jersey, New York, North Carolina, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0695-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0695-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.