HawkOne™ H1-S (UDI 00643169792319)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169792319), received between Sep 21, 2017 and Jan 9, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (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.

Recalls naming this device

1. Dec 6, 2021Terminated

   Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

   Z-0451-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2018Break; Break

  THE PHYSICIAN USED A HAWKONE ATHERECTOMY DEVICE TO TREAT PLAQUE AND SOFT TISSUE LESIONS WITH LITTLE CALCIFICATION IN THE LEFT PROXIMAL TIBIAL ARTERY AND POPLITEAL TRUNK. THE LESIONS LENGTHS WERE 15-20 MM AND THE ARTERY DIAMETERS WERE 2-5 MM. THE ARTERIES HAD LITTLE TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR 55 CM SHEATH AND A NON MEDTRONIC 300CM GUIDEWIRE. THE VESSEL WAS PRE AND POST DILATED. PRE DILATION WAS CARRIED OUT WITH A NANOCROSS DEVICE AND POST DILATION WAS CARRIED OUT WITH A DRUG COATED BALLOON(DCB). FOLLOWING THE SECOND ROUND OF CUTTING THE BUTTON OF THE DEVICE WOULD NOT GO FORWARD AND BECAME STUCK. THE DEVICE WAS REMOVED SAFELY FROM THE PATIENT BUT IT WAS UNKNOWN IF THE CUTTER HAD RETURNED INTO THE HOUSING ON REMOVAL. ANGIOGRAM SHOWED GOOD RUN OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175497 ↗
• MalfunctionDec 19, 2017Kinked; Detachment of Device or Device Component; Kinked; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DEVICE TO TREAT A 100 MM, SEVERELY CALCIFIED, CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID LEFT ANTERIOR TIBIAL ARTERY. THE VESSEL HAD A DIAMETER OF 2.5 MM AND HAD LITTLE TORTUOSITY. THE PROCEDURE USED A NON-MEDTRONIC 6 FR 90 CM SHEATH AND A NON-MEDTRONIC 300 CM GUIDEWIRE ALONG WITH THE HAWKONE DEVICE. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AS THE CATHETER WAS BEING REMOVED IT BECAME DIFFICULT TO WITHDRAW IT THROUGH THE SHEATH DUE TO SEVERE RESISTANCE. IT WAS REPORTED THAT THE NOSECONE BECAME SEPARATED AND LODGED IN THE SHEATH. A KINK WAS FOUND IN THE MID TO DISTAL WIRE AFTER THE SHEATH WAS REMOVED. A NEW SHEATH WAS INSERTED AND ACCESS RE-ESTABLISHED. PTA WAS PERFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128063 ↗
• MalfunctionSep 21, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE 350 MM LESION (TYPE FIBROUS AND PLAQUE WITH LITTLE CALCIFICATION). A DIFFUSE VESSEL WAS THE TARGET FOR TREATMENT: TPT ALL THE WAY DOWN TO THE PT AND PLANTER ARCH, THE LESION HAD BEEN TREATED THE WEEK PREVIOUS WITH A PHOENIX DEVICE. PATIENT HAS BEEN A FREQUENT RETURNER. THE VESSEL DIAMETER WAS 4.0 MM WITH LITTLE TORTUOSITY AND 95% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. A 6 FRENCH 70 CM NON MEDTRONIC SHEATH WAS USED WITH A 0.014" NON MEDTRONIC 300CM GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. THE VESSEL WAS PRE AND POST-DILATED. THE PHYSICIAN WAS MET WITH SEVERE RESISTANCE DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS FELT WHEN GOING THROUGH THE SHEATH AND THE TIP OF THE DEVICE SEPARATED AT THE HINGE PIN NEAR THE CUTTER BLADE AND HAD A TWISTED APPEARANCE. THE GUIDEWIRE DID NOT PROLAPSE. THERE WAS NO EMBOLIZATION REPORTED. THE DETACHED TIP REMAINED WITHIN THE SHEATH. THE SHEATH WAS REMOVED WITH BROKEN TIP FULLY REMAINING INSIDE SHEATH,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883695 ↗

Recalls under the same FDA submission

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

• 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