HawkOne™ H1-M (UDI 00643169728769)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169728769), received between Dec 6, 2016 and Apr 23, 2020 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A HAWKONE ONE ATHERECTOMY CATHETER TO TREAT A LESION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES I ENTIFIED. THE PROCEDURE USED A 0.014" GUIDEWIRE AND A 6 FR SHEATH. THE VESSEL WAS NOT PRE-DILATED. FOLLOWING THE SECOND CLEANING OF THE DEVICE THE TIP DETACHED OUTSIDE OF THE PATIENT. THE TIP DID NOT SEPARATE AT THE HINGE PIN. NO RESISTANCE WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED BY POST DILATION WITH AN IPA BALLOON CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992009 ↗
• MalfunctionMar 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY CATHETER TO TREAT A 20MM SEVERELY CALCIFIED LESION (90% STENOSIS) IN THE PROXIMAL RIGHT SFA. THE VESSEL HAD LITTLE TORTUOSITY AND A 7MM DIAMETER. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6FR 70CM NON-MEDTRONIC SHEATH AND A 7MM SPIDER .014¿ FILTER WIRE. THE VESSEL WAS PRE-DILATED BUT WAS NOT POST-DILATED. THE GUIDEWIRE WAS HYDRATED AT PREPARATION. THE DEVICE WAS ADVANCED OVER BIFURCATION. SEVERE RESISTANCE WAS EXPERIENCED DURING WITHDRAWAL AND WIRE WRAP AROUND THE CATHETER OCCURRED. THIS CAUSED THE WIRE TO LOOP DURING ATTEMPTED REMOVAL OF THE DEVICE FROM THE PATIENT AND THE DEVICE LOCKED UP ON THE WIRE. THE DEVICE TIP BROKE OFF INSIDE THE SHEATH BUT THE DEVICE AND TIP WERE REMOVED WITH THE SHEATH. THE SPIDER WIRE REMAINED INSIDE THE PATIENT AS THE ONLY ACCESS TO VESSEL. THE PHYSICIAN CUT THE 0.014" SPIDER WIRE OUTSIDE THE PATIENT TO PREVENT THE WIRE FROM BEING PULLED OUT THROUGH THE GROIN ACCESS SITE. THE PHYSICIAN THEN ATTEMPTED TO PASS A NEW 10CM 5FR NON-MEDTRONIC MICROPUNCTURE SHEATH OVER THE SPIDER WIRE INTO THE COMMON FEMORAL ARTERY AT THE ACCESS SITE BUT THIS WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323818 ↗
• MalfunctionAug 30, 2017Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN INTENDED TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 7 FRENCH NON-MEDTRONIC SHEATH AND 5MM SPIDER FX EMBOLIC PROTECTION FILTER WIRE FOR THE TREATMENT OF A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID POPLITEAL ARTERY. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). IFU WAS FOLLOWED. IT WAS REPORTED THAT SEVERE RESISTANCE WAS FELT DURING WITHDRAWAL OF THE DEVICE AND THAT THE TIP SEPARATED AT THE HINGE PIN. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. IT WAS REPORTED THAT THE NOSECONE WAS STUCK IN THE SHEATH. FORCE WAS APPLIED AND THE NOSECONE BROKE INTO THREE PIECES. ALL PIECES WERE RECOVERED IN THE SHEATH. THE CUTTER WAS INSIDE THE HOUSING FOR THE SAFE REMOVAL OF THE DEVICE. DEFORMATION WAS NOTED TO THE CUTTER BUT NO PIECES WERE NOTED TO BE MISSING. THE PROCEDURE WAS COMPLETED AS LESION WAS DILATED WITH POBA, AND THEN IN.PACT ADMIRAL DRUG COATED BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6829445 ↗
• MalfunctionJun 9, 2017Split; Split

  PHYSICIAN WAS USING A HAWKONE M DEVICE WITH A 6F SHEATH AND 5MM .014 EMBOLIC PROTECTION DEVICE FOR TREATMENT OF A 200MM NON-TORTUOUS MODERATELY CALCIFIED LESION WHICH EXHIBITED 100% LESION STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. THE IFU WAS FOLLOWED AND THE VESSEL WAS NOT PRE-DILATED. MULTIPLE PASSES WERE MADE DOWN THE SFA WITHOUT ISSUE. THE DEVICE WOULD THEN NOT FLUSH. THE NOSE CONE WAS REMOVED FROM THE TOOL AND A BREAK WAS OBSERVED IN THE NOSE CONE. THE NOSE CONE HAD PLAQUE BREAKING THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW DEVICE. VESSEL WAS POST-DILATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628995 ↗
• MalfunctionJun 5, 2017Material Integrity Problem; Material Integrity Problem

  THE PHYSICIAN INTENDED TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. IT WAS REPORTED THE HAWKONE DEVICE STARTED KICKING BACK IN VESSEL WHILE CUTTING AFTER ONLY A FEW SMALL PASSES. THE PACKER COULD NOT BE SEEN OVER X-RAY. WHEN REMOVED FROM THE PATIENT, IT WAS VISIBLE THAT THE NOSECONE WAS ALMOST COMPLETELY DETACHED FROM CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6611062 ↗
• MalfunctionMay 19, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE M DEVICE WITH A 6FR ANSEL COOK SHEATH AND 0.014 SPARTACORE GUIDEWIRE FOR THE TREATMENT OF A MODERATELY CALCIFIED PLAQUE LESION OF LENGTH 150 MM WHICH EXHIBITED 60-70% STENOSIS LOCATED IN THE RIGHT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (DIAMETER 4 MM). DEVICE WAS PREPPED AS PER IFU. ONCE LOADED ONTO THE SPARTACORE, PHYSICIAN ADVANCED THE CATHETER INTO THE LESION SITE AND MADE THREE CUTS RESULTING IN THE NOSECONE FILLING UP. THE TISSUE WAS UNABLE TO BE FLUSHED AS THE BULGING ON THE NOSECONE WOULD NOT ALLOW THE DFT OVER IT. THE CATHETER WAS SAFELY REMOVED FROM THE PATIENT FOR CLEANING. DURING CLEANING THE NOSE CONE, THE BULGE WAS OBSERVED. THE TECH TRIED TO ADVANCE THE DFT OVER THE NOSE CONE BUT HAD DIFFICULTY. A NEW CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579908 ↗
• MalfunctionMay 2, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE DURING PROCEDURE FOR TREATMENT OF THE RIGHT MID SUPERFICIAL FEMORAL ARTERY. THE PLAQUE LESION EXHIBITED LITTLE TORTUOSITY AND CALCIFICATION WITH CHRONIC TOTAL OCCLUSION (100%). THE ARTERY DIAMETER IS REPORTED AS 6MM WITH A LESION LENGTH OF 300MM. A 6F TERUMO SHEATH AND 6MM SPIDER 0.014 GUIDEWIRE WERE USED DURING PROCEDURE. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. IT IS REPORTED THAT THE BLADE WAS UNABLE TO BE ADVANCED BACK INTO THE NOSECONE AND THE DEVICE COULD NOT BE PACKED. A NEW H1-M WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH IT. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6539502 ↗
• MalfunctionApr 13, 2017Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE LEFT SFA USING HAWKONE ATHERECTOMY AND SPIDER DISTAL EMBOLIC PROTECTION. IT WAS REPORTED THAT A KINK OCCURRED WITH THE SPIDER DEVICE DURING THE SECOND WITHDRAWAL. RESISTANCE WAS FELT DURING WITHDRAWAL. THE KINK WAS OBSERVED AT SHEATH TIP. THE GUIDE WIRE WAS ALSO KINKED. THE ATHERECTOMY WAS ADVANCED OVER A BIFURCATION AND GUIDE WIRE ADVANCEMENT/PROLAPSE/LOCK-UP OCCURRED. MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL. TIP WAS DAMAGED. GUIDE WIRE LUMEN TORN FROM DISTAL TIP. PROLAPSE OCCURRED DURING DEVICE REMOVAL FOR CLEANING. SHEATH, WIRE AND DEVICE WERE REMOVED IN UNISON LEAVING A DISTAL PORTION ON SPIDER IN CONTRALATERAL VESSEL. COAXIAL CATHETERS WERE USED TO REPLACE SHEATH AND NEW SPIDER AND DEVICE WERE USED TO FINISH PROCEDURE. PROLAPSE OCCURRED DURING DEVICE REMOVAL FOR CLEANING. THE TWO DEVICES WERE REMOVED IN TANDEM. THE LESION WAS SEVERELY CALCIFIED AND TOTALLY OCCLUDED, VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS PRE AND POST DILATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489659 ↗
• InjuryMar 9, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING A LESION IN THE SFA USING A HAWKONE ATHERECTOMY DEVICE. THE LESION EXHIBITED 90% STENOSIS AND WAS SEVERELY CALCIFIED. IT WAS REPORTED THAT THE DEVICE WAS USED FOR SEVERAL PASSES. WHEN IT WAS BEING WITHDRAWN THROUGH THE PROXIMAL SFA THE NOSECONE OF THE DEVICE SEPARATED. IT WAS REPORTED THAT A 6F SHEATH WAS REPLACED BY AN 8F SHEATH. THEN A 10MM SNARE WAS USED TO REMOVE THE TIP AND SPIDER. THE PROCEDURE WAS COMPLETED BY PLACING A 0.035¿ WIRE UP AND OVER TO THE TIBIAL ARTERY. THEN THE ENTIRE SFA WAS PREDILATED WITH A 4 X 200 MM EVERCROSS BALLOON. THEN DISTAL TO THE PROXIMAL SFA, A 5X150, A 6X150 AND A 6X80 INPACT ADMIRALS WERE DEPLOYED. THE FINAL RUNOFF SHOWED OPEN AND PATENT VESSEL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6391286 ↗
• MalfunctionFeb 16, 2017Break; Break

  PHYSICIAN WAS PERFORMING AN ATHERECTOMY PROCEDURE ON A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY USING A HAWK ONE DEVICE. THE VESSEL WAS NOT PRE-DILATED. THE LESION EXHIBITED SEVERE CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO ADVANCE THE THUMB SWITCH FORWARD FULLY AFTER EACH PASS. AFTER REMOVING AND CLEANING THE DEVICE, IT FAILED TO PACK TISSUE INTO THE NOSE CONE. A SECOND HAWKONE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6338211 ↗
• MalfunctionJan 3, 2017Fracture; Defective Device; Fracture; Defective Device

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE RIGHT SFA USING ATHERECTOMY. THE LESION WAS REPORTED TO HAVE EXHIBITED NO CALCIFICATION OR TORTUOSITY WITH 70% STENOSIS. THE VESSEL DIAMETER WAS REPORTED TO BE 6MM AND LESION LENGTH WAS REPORTED TO BE 60MM. IT WAS REPORTED THAT THE DEVICE WOULD NOT CLOSE. MULTIPLE ATTEMPTS WERE MADE TO DEBULK AND CLOSE THE DEVICE. IT WAS REPORTED THAT TISSUE WAS CAPTURED BUT THE THUMB SWITCH WOULD NOT MOVE FORWARD. ONCE REMOVED FROM THE PATIENT, IT WAS REPORTED THAT THE DEVICE WAS ABLE TO BE OPENED AND CLOSED. A DCB BALLOON WAS USED TO POST DILATE THE LESION WITH EXCELLENT RESULTS. THERE WAS NO INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6218384 ↗
• InjuryJan 3, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE LEFT MID/DISTAL TIBIAL ARTERY AND TIBIAL/POPLITEAL TRUNK USING A HAWKONE DIRECTIONAL ATHERECTOMY. TARGET LESION TYPE WAS "PLAQUE" AND HAD LITTLE TORTUOSITY, LITTLE CALCIFICATION AND 100% STENOSIS (CTO). A 6F SHEATH AND .014¿/3 MM SPIDER EMBOLIC PROTECTION DEVICE WERE ALSO USED. VESSEL WAS NOT PRE-DILATED. IFU WAS FOLLOWED. IT IS REPORTED THAT DEVICE WAS OPERATING NORMAL AT FIRST. WHEN NOSECONE WAS 3/4 FULL, THE NOSECONE BEGAN TO PACK MORE DISTALLY. THE NOSECONE THEN TORE AND PLAQUE EMBOLIZED DOWNSTREAM. PROCEDURE WAS COMPLETED USING IPA DCB'S, STENTS AND CORONARY DES IN TIBIAL BIFURCATION. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Embolism

  MAUDE report 6218308 ↗
• MalfunctionJan 3, 2017Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED LESION WITH SEVERE TORTUOSITY AND 90% IN THE RIGHT SFA USING SPIDER FX AND 2 HAWKONE ATHERECTOMY DEVICES. THE LESION WAS PRE AND POST DILATED. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCE SEVERE RESISTANCE DURING WITHDRAWAL OF THE FIRST HAWKONE DEVICE AND THE TIP BROKE AND SEPARATED. THE GUIDEIWRE LOCKED UP ON THE CATHETER. A SPIDER WIRE WAS CAUGHT ON THE HAWK ONE. THE WIRE PULLED OUT OF WIRE PORT ON TIP, BOTH WERE REMOVED IN TANDEM. THEN A 2ND HAWKONE WAS USED. IT WAS REPORTED THAT THE SECOND HAWKONE WOULD NOT PACK AND A THIRD HAWKONE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6217762 ↗
• MalfunctionDec 6, 2016Defective Device; Defective Device

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED LESION WITH LITTLE TORTUOSITY IN THE SFA OF A PATIENT USING HAWKONE ATHERECTOMY DEVICE, IT WAS REPORTED THAT THE THUMB SWITCH JAMMED. DEVICE WAS CLEANED AFTER FIRST INSERTION. SECOND INSERTION THUMB SWITCH STILL DID NOT FEEL NORMAL TO TECH. AFTER ONE PASS THE PHYSICIAN NOTICED THE CUTTER BLADE ON ANGIO WAS OUTSIDE OF NOSE CONE AND WOULD NOT GO BACK INTO CUTTER WINDOW. PHYSICIAN DID NOT FINISH CUTTING THE LESION AND REMOVED THE DEVICE THROUGH THE SHEATH. PHYSICIAN USED DCB ON REMAINING STENOSIS. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6147530 ↗

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