HawkOne H1-LXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821684057933), received between Apr 14, 2017 and May 16, 2018 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2018Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  THE PHYSICIAN INTENDED TO USE THE USE THE HAWKONE LX 7F, TO TREAT A 450 MM FIBROUS PLAQUE LESION WITH 90% STENOSIS, IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. ARTERY DIAMETER WAS 6 MM. IT WAS REPORTED THE PHYSICIAN USED A CONTRA LATERAL APPROACH, WITH 7FR NON MEDTRONIC SHEATH. IT WAS REPORTED THE SFA WAS DIFFUSELY DISEASED ABOUT 90-99% IN THE ENTIRE SFA WITH A HEALTHY POPLITEAL ARTERY. A 6X40 NON-MEDTRONIC STENT WAS USED FROM THE OSTIUM OF SFA AND 6X150 NON-MEDTRONIC STENT IN THE HUNTERS CANAL EXTENDING TO POPLITEAL. A GUIDE CATHETER AND STIFF 0.035 GUIDEWIRE WAS USED TO CROSS SFA, THEN IT WAS EXCHANGED FOR A 0.014 NON MEDTRONIC 300 MM WIRE. THE H1-LX WAS PREPPED PER IFU WITH NO VISIBLE DAMAGE NOTED AND INSERTED INTO THE PATIENT TO TREAT THE ENTIRE SFA. AFTER SEVERAL PASSES WERE MADE, THE NOSECONE WAS FILLING UP AND THE PHYSICIAN STARTED TO FEEL A LITTLE RESISTANCE WHEN PACKING THE DEVICE. THE CATHETER WAS SAFELY REMOVED FOR CLEANING. AFTER CLEANING WAS PERFORMED PER IFU, THE CATHETER WAS INSPECTED AND NO VISIBLE DAMAGE WAS NOTED. THE DEVICE WAS TURNED ON AND OFF SEVERAL TIMES TO INSPECT THE CUTTER BLADE AND IT WAS REPORTED TO HAVE BEEN WORKING PROPERLY. THE CATH

  Patient problems: Embolism

  MAUDE report 7518136 ↗
• MalfunctionMar 7, 2018Device Damaged by Another Device; Device Damaged by Another Device

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY CATHETER TO TREAT A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION -100% IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY(SFA). THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 0.014" NITREX GUIDEWIRE. IT WAS REPORTED THAT THE WIRE SPLIT THROUGH THE WIRE PORT DURING ATHERECTOMY. THE PROCEDURE WAS COMPLETED BY ANGIOPLASTY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320884 ↗
• MalfunctionOct 18, 2017Material Integrity Problem; Material Integrity Problem

  THE PHYSICIAN WAS USING A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION COMPOSED OF CALCIFICATION, FIBROUS MATERIAL AND PLAQUE IN THE RIGHT MID SFA. THE LESION WAS 200MM IN LENGTH, THE ARTERY WAS 5 MM IN DIAMETER AND HAD NO TORTUOSITY. THE DEVICE WAS PREPPED AND INSERTED AS PER IFU. THE SHEATH USED WAS NON-MEDTRONIC 7 FR, 45 CM IN LENGTH. IT WAS REPORTED THAT AFTER COMPLETING THREE SUCCESSFUL PASSES WITH THE DEVICE, IT WAS RE-INSERTED FOR FURTHER CUTTING AFTER CLEANING. IT WAS NOTED THAT IT SOUNDED DIFFERENT AND WAS NOT CUTTING PROPERLY. A PIECE OF METAL WAS NOTED AS SHOWING AROUND THE TRIGGER AND THE TRIGGER COULD NOT FUNCTION CORRECTLY. THE MOTOR WOULD TURN ON, BUT THE METAL WOULD NOT ALLOW FOR FULL ENGAGEMENT OF THE CUTTER. THERE WAS NO DAMAGE NOTED TO THE DISTAL TIP OR ANY ISSUES PACKING THE NOSECONE. THE CUTTER DRIVER WAS NEVER SEPARATED FROM THE HOUSING. NO ISSUES WERE FOUND INSERTING THE DRIVER INTO THE CATHETER. THE DEVICE WAS REMOVED AND ANOTHER HAWK ONE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6957252 ↗
• MalfunctionAug 25, 2017Mechanical Problem; Mechanical Problem

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND 7.0 SPIDER FX EMBOLIC PROTECTION DEVICE FOR THE TREATMENT OF A 250MM SLIGHTLY CALCIFIED PLAQUE LESION IN THE LEFT SFA OF DIAMETER 6MM. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). IFU FOLLOWED AND DEVICE PREPPED WITHOUT ISSUE. VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WOULD NOT PACK AND THUMB SWITCH WOULD NOT ADVANCE. THIS OCCURRED AFTER THE 3RD PASS OF THE 4TH RUN. THE DEVICE HAD BEEN CLEANED SUCCESSFULLY ON THE 3 PREVIOUS RUNS. THE THUMB SWITCH COULD BE TURNED OFF BUT IT WAS DIFFICULT. THE CUTTER COULD NOT BE PACKED. NO DEFORMITY IN THE CUTTER WAS OBSERVED. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THE VESSEL WAS POST-DILATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6822341 ↗
• MalfunctionAug 11, 2017Material Deformation; Material Deformation

  PHYSICIAN EMPLOYED THE USE OF A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 7FR 45CM NON-MEDTRONIC SHEATH AND A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF AN IN-STENT RESTENOSIS (ISR) IN THE MID/PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). PLAQUE LESION EXHIBITED 90% STENOSIS. IT WAS REPORTED THAT THERE WAS DAMAGE NOTED TO THE CUTTER DURING THE PROCEDURE. NO STENT INTERACTION WAS NOTED. STENT WAS STILL IN PLACE. THUMB SWITCH WOULD NOT ADVANCE CUTTER INTO NOSECONE PROPERLY. NO DAMAGED COMPONENT NEEDED TO BE RETRIEVED FROM THE PATIENT. THE CUTTER WAS HALF OUTSIDE THE HOUSING FOR REMOVAL OF DEVICE FROM THE PATIENT. FOLLOW UP ANGIOPLASTY WITH DRUG-COATED BALLOON (DCB) WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6789487 ↗
• MalfunctionAug 4, 2017Device-Device Incompatibility; Device-Device Incompatibility

  PHYSICIAN WAS USING A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE FOR TREATMENT OF A CALCIFIED PLAQUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE IFU WAS FOLLOWED. THERE WAS NO RESISTANCE ENCOUNTERED IN ADVANCING DEVICE. IT WAS REPORTED THAT DURING THE FOURTH CLEANING OF THE DEVICE, THE DEVICE COULD NOT BE FLUSHED. THE DEVICE WAS SUCCESSFULLY USED AND CLEANED UP UNTIL THIS WITHOUT ISSUE. THE DEVICE DID NOT WANT TO TURN OFF AT THE THUMBSWITCH, SO THE PHYSICIAN TURN OFF BATTERY AND MANUALLY HOLD THUMB SWITCH IN OFF POSITION TO REMOVE. THERE WAS NO DEFORMATION NOTED TO THE CUTTER. ANOTHER HAWKONE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769184 ↗
• MalfunctionJun 23, 2017Break; Material Distortion; Break; Material Distortion

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE FOR TREATMENT OF A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION LOCATED IN PROXIMAL LOCATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE IFU WAS FOLLOWED. NO ALLEGED PRODUCT ISSUE. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE NOSE CONE SEPARATED FROM THE CATHETER. IT REMAINED ATTACHED BUT WAS SEPARATED SO COULD NOT BE USED AGAIN. THIS OCCURRED OUTSIDE OF PATIENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6665659 ↗
• MalfunctionMay 5, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE LEFT (PROXIMAL, MID AND DISTAL) SUPERFICIAL FEMORAL ARTERY USING A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE. TARGET LESION TYPE WAS PLAQUE AND FIBROUS. LESION DISPLAYED NO TORTUOSITY, LITTLE CALCIFICATION AND 100% STENOSIS. A 7F SHEATH AND 0.014" GUIDEWIRE WERE USED. VESSEL WAS NOT PRE-DILATED. IFU WAS FOLLOWED. IT IS REPORTED THAT DURING USE, THE NOSE CONE RUPTURED AND PLAQUE WAS PROTRUDING OUT THE SIDE. PROCEDURE WAS COMPLETED USING A SECOND DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549701 ↗
• MalfunctionApr 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A TRAILBLAZER CATHETER, 1 IN.PACT ADMIRAL DRUG-COATED BALLOON (DCB), 1 POWERCROSS BALLOON AND A HAWKONE LX 7F DEVICE TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE IFU INSTRUCTIONS FOR USE WERE NOT FOLLOWED; THE PHYSICIAN USED THE HAWKONE TO TREAT AN IN-STENT RESTENOSIS. IT WAS REPORTED THE HAWKONE DID NOT GET CAUGHT ON THE STENT, THE STENT REMAINS IN THE PATIENT. IT WAS REPORTED THAT RESISTANCE WAS FELT WHILE WITHDRAWING THE HAWKONE DEVICE, AND THE GUIDEWIRE LOCKED UP ON THE CATHETER; THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. THE CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE, DCB AND STENT. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6493891 ↗