TurboHawk™ TH-LX-M (UDI 00821684065754)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821684065754), received between Sep 13, 2017 and Mar 5, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2019Mechanical Problem; Mechanical Problem

  THE PHYSICIAN WAS USING A TURBOHAWK ATK TO TREAT AN 80MM FIBROUS LESION WITH 50% STENOSIS IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION EXHIBITED LITTLE CALCIFICATION AND LITTLE TORTUOSITY WAS REPORTED. A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC 014 WIRE WERE USED FOR THE PROCEDURE. THE DEVICE WAS PREPPED WITH NO ISSUES. THE TURBOHAWK ATK WAS ADVANCED THROUGH THE SHEATH IN THE LEFT GROIN AND TRACKED UP OVER THE BIFURCATION WITH NO ISSUES. THE DEVICE TURNED ON AND PASSED THROUGH THE LESION WITH NO ISSUES. IT WAS REPORTED THAT UPON TRYING TO PACK THE DEVICE, THE CUTTER WOULD NOT ADVANCE FORWARD. AS THE DEVICE WOULD NOT PACK, IT WAS REMOVED OVER THE WIRE AND EXCHANGED FOR ANOTHER TUBOHAWK ATK. THERE WAS NO EMBOLISM REPORTED AND THE PATIENT DID NOT HAVE ANY COMPLICATIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8389557 ↗
• MalfunctionMay 9, 2018Device Operational Issue; Device Operational Issue

  PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE FOR TREATMENT OF A SLIGHTLY CALCIFIED SOFT TISSUE LESION WITH LITTLE TORTUOSITY IN THE PATIENTS MID SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO USE WITHOUT ISSUE. IT IS REPORTED THE DEVICE BECAME JAMMED AND WOULD NOT CLOSE. THE PHYSICIAN COULD TURN THE CUTTER OFF BUT NOT COMPLETELY FORWARD. THE CUTTER WAS BARELY CLOSED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE SAME ISSUE IS REPORTED FOR A SECOND TURBOHAWK DEVICE USED IN THE PROCEDURE. A THIRD DEVICE H1-LX WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497768 ↗
• MalfunctionMay 9, 2018Device Operational Issue; Material Deformation; Device Operational Issue; Material Deformation

  PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE FOR TREATMENT OF A SLIGHTLY CALCIFIED SOFT TISSUE LESION IN THE PATIENTS MID SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE DEVICE BECAME JAMMED AND WOULD NOT CLOSE. THE PHYSICIAN COULD TURN THE CUTTER OFF BUT NOT COMPLETELY FORWARD. THE SAME IS REPORTED FOR A SECOND DEVICE IN THE PROCEDURE. THE CUTTER WAS BARELY CLOSED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. A THIRD DEVICE H1-LX WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497748 ↗
• MalfunctionDec 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A LESION IN AN UNKNOWN LOCATION. A NON-MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE PHYSICIAN REPORTED THAT THEY WERE ABLE TO OPEN THE CUTTER AND OPERATE THE DEVICE WITHIN THE LESION, BUT THE DEVICE WOULD NOT COMPLETELY CLOSE. THERE WAS NO ISSUE PACKING THE NOSECONE. IT IS UNKNOWN IF THE CUTTER WAS RETURNED FULLY TO THE HOUSING BEFORE THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMMENTED THAT IT WAS POSSIBLE THAT A PIECE OF PLASTIC FROM THE GUIDE CATHETER MIGHT BE LODGED IN THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123510 ↗
• MalfunctionNov 29, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 400 MM SOFT TISSUE CHRONIC TOTAL OCCLUSION IN THE SFA. THE VESSEL WAS REPORTED TO HAVE HAD NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A SPIDER FILTER WIRE AND A 7FR NON-MEDTRONIC SHEATH. IT WAS REPORTED THAT THE DEVICE JAMMED AND WOULD NOT CLOSE. TWO INSERTIONS OF THE DEVICE AND AROUND 4 PASSES WERE MADE WITH EACH INSERTION WHEN IT WAS NOTICED THAT THE DEVICE NOT PACKING. THE CUTTER COULD NOT BE RETURNED TO THE HOUSING. THE PROCEDURE WAS COMPLETED USING ANOTHER TURBOHAWK DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068023 ↗
• MalfunctionNov 8, 2017Device Inoperable; Device Inoperable

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A PLAQUE CHRONIC TOTAL OCCLUSION IN THE SFA AND POPLITEAL ARTERY. THE LESION WAS 400 MM IN LENGTH. THE ARTERY DIAMETER WAS 5-6 MM WITH LITTLE TORTUOSITY. 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 0.014" NON-MEDTRONIC GUIDEWIRE WAS USED WITH A 7 FR NON-MEDTRONIC SHEATH. THE VESSEL WAS NOT PRE-DILATED, BUT WAS POST-DILATED. THE PHYSICIAN WAS NOT MET WITH RESISTANCE DURING ADVANCEMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CUTTER GOT STUCK IN THE CUTTER MOUTH AND WOULD NOT ADVANCE BACK INTO THE NOSE CONE. THE DEVICE WAS CLEANED ONCE, AND MALFUNCTIONED OCCURRED ON THE SECOND PASS AFTER THE FIRST CLEANING. NO DAMAGE WAS NOTED TO THE FLUSH PORT ON THE CATHETER HANDLE. A SECOND TURBOHAWK DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012209 ↗
• MalfunctionSep 13, 2017Retraction Problem; Device Operates Differently Than Expected; Retraction Problem; Device Operates Differently Than Expected

  THE PHYSICIAN WAS USING A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT SFA LESION EXHIBITING 75% STENOSIS AND PLAQUE. THE DEVICE WAS REMOVED FROM THE PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY INSERTED THE DEVICE INTO THE PATIENT, MADE SIX PASSES, THEN REMOVED AND CLEANED THE DEVICE BEFORE RE-ADVANCING THE DEVICE THROUGH THE SHEATH AND MAKING SEVERAL MORE PASSES THROUGH THE LESION. THE PHYSICIAN REPORTED THAT THEY WERE UNABLE TO TURN THE DEVICE ON AND OFF WITHOUT THE THUMBSWITCH STICKING WHILE AT TIMES, BEING USED IN THE PATIENT. IT WAS REPORTED THAT THE DEVICE WAS STICKING WHILE THE CUTTER WAS BOTH INSIDE AND OUTSIDE THE HOUSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6863940 ↗