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

Recall Z-0451-2022 — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter

U.S. FDA — Device Enforcement · United States · 2021-12-06 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0451-2022
Date of alert: 2021-12-06
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: ev3 Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00643169792319

Reported risk: Reports have been received of tip damage during use of the devices which resulted in some 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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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