HawkOne™ H1-14550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169968554), received between May 21, 2019 and May 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K141801, K161361); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED A HAWKONE H1-M DEVICE WITH A NON-MEDTRONIC 6FR SHEATH AND A 4.0MM SPIDER FX EMBOLIC PROTECTION DEVICE TO TREAT A 20MM SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL RIGHT POPLITEAL ARTERY OF 5MM DIAMETER. SLIGHT TORTUOSITY WAS REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. NO RESISTANCE WAS FELT DURING ADVANCEMENT. THE DEVICE STOPPED PACKING AFTER A COUPLE OF PASSES. THE PHYSICIAN REMOVED IT TO CLEAN BUT IT WOULD ONLY ADVANCE ABOUT ONE THIRD OF THE WAY AFTER CLEANING. IT WAS REPORTED TO HAVE BEEN FLUSHED MULTIPLE TIMES WITH NO VISIBLE TISSUE OBSERVED BUT THE CUTTER WOULD NOT PACK MORE THAN ONE THIRD OF THE WAY. THE DEVICE WAS REPLACED WITH A NEW HAWKONE H1-M TO COMPLETE THE ATHERECTOMY FOLLOWED BY A 5X40 CHOCOLATE PTA BALLOON AND A 5X40 INPACT ADMIRAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627844 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141801, K161361. One submission often covers many models, so check the product and lot details in each record.

• Z-0451-2022 · Dec 6, 2021 · Terminated
  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 HawkO
• Z-0450-2022 · Dec 6, 2021 · Terminated
  Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The Haw