Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0695-2022 — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

U.S. FDA — Device Enforcement · United States · 2022-02-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0695-2022
Date of alert
2022-02-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
ev3 Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000402419
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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