HawkOne™ H1-S (UDI 00643169728783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169728783), received between Jun 15, 2017 and Nov 7, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

2 other recalls 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 60 MM FIBROUS LESION WITH LITTLE CALCIFICATION IN THE DISTAL SFA. THE ARTERY WAS NON-TORTUOUS, 5 MM IN DIAMETER AND HAD 70% STENOSIS. THE PROCEDURE USED A 6FR NON-MEDTRONIC 45 CM SHEATH AND 5 MM EMBOLIC PROTECTION. THE LESION WAS NOT PRE-DILATED BUT WAS POST-DILATED. THE HAWKONE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE GUIDEWIRE WAS HYDRATED AT PREPARATION. THE HAWKONE WAS ADVANCED OVER THE BIFURCATION. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE WHILE WITHDRAWING THE DEVICE, AND THE WIRE RIPPED THROUGH THE WIRE LUMEN ON NOSECONE WHEN REMOVING AT SHEATH. THE TIP DID NOT SEPARATE AT THE HINGE POINT. THE GUIDEWIRE DID NOT LOCK UP ON THE CATHETER AND THE GUIDEWIRE LUMEN WAS NOT TORN ON THE DISTAL TIP. THE PHYSICIAN DID NOT NOTICE THE GUIDEWIRE PROLAPSE. A NEW HAWKONE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008598 ↗
• MalfunctionJun 15, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY USING A HAWKONE DIRECTIONAL ARTHERECTOMY DEVICE AND SPIDER EMBOLIC PROTECTION DEVICE. VESSEL WAS PRE AND POST-DILATED. DEVICE WAS ADVANCED OVER A BIFURCATION. IT IS REPORTED THAT HAWKONE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO SEVERE RESISTANCE. SEVERE RESISTANCE WAS ALSO EXPERIENCED WHEN ATTEMPTING TO WITHDRAW. IT IS REPORTED THAT GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP AND ALLOWED THE 0.014" GUIDEWIRE TO PROTRUDE. SPIDER WIRE THEN LOCKED UP AROUND THE NOSECONE. SYSTEM WAS REMOVED IN TANDEM. PROCEDURE WAS COMPLETED BY ADVANCING A 0.035" GUIDEWIRE TO TIBIAL AND STENTING/PTA WAS PERFORMED. NO PATIENT INJURY REPORTED. WHEN DEVICE WAS RETURNED FOR ANALYSIS IT WAS NOTED THE GUIDEWIRE LUMEN HAD BEEN ZIPPERED BY THE SPIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645908 ↗

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-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