TurboHawk™ THS-LX-C (UDI 00821684074008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00821684074008), received between Sep 13, 2017 and Jul 2, 2020 — classified as 13 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K111723); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE TURBOHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED PLAQUE IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT WHEN THE SWITCH WAS OPERATED, THE CUTTER WAS STUCK AND COULD NOT BE RETRACTED, AND RESISTANCE WAS FELT. IT WAS POSSIBLE TO ADVANCE THE CUTTER WITHIN THE HOUSING AND THEY WERE UNABLE TO RETRACT THE CUTTER INTO THE CUTTER WINDOW. THE CUTTER WAS LOCATED OUTSIDE THE CUTTER WINDOW. IT WAS NOT POSSIBLE TO TURN THE THUMBSWITCH OFF. THE CUTTER DRIVER/THUMBSWITCH DID NOT STOP FUNCTIONING WHILE IN USE IN PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO DEFORMATION NOTED IN THE CUTTER. NO PIECES OF THE CUTTER WERE MISSING. A NON-MEDTRONIC PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223250 ↗
• MalfunctionFeb 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. DEVICE INSPECTED PRIOR TO USE WITHOUT ISSUE. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED DURING USE, INSIDE THE PATIENT, THE DEVICE JAMMED AND WOULD NOT CLOSE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS COMPETED WITH ANOTHER DEVICE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664154 ↗
• MalfunctionOct 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY DEVICE IN A PROCEDURE TO TREAT A SEVERELY CALCIFIED PLAQUE LESION IN THE MID SFA TO POPLITEAL WITH 70% STENOSIS. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING THE INTERNAL CUTTING PROCESS, THE CUTTER FELL INTO THE COLLECTION CHAMBER AND FELL OFF. THE COLLECTION MODULE WAS STILL CONNECTED TO THE DEVICE. THE CUTTER HEAD DID NOT DETACH IN THE PATIENT. THE CUTTER FELL IN THE COLLECTION CHAMBER, NOT IN THE BLOOD VESSEL. IT WAS REMOVED FROM PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236838 ↗
• MalfunctionJun 14, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A TURBOHAWK ATK DEVICE TO TREAT A 200MM CALCIFIED, FIBROUS 85% STENOTIC LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5-6MM. SEVERE TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE DEVICE JAMMED AND WOULD NOT CLOSE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699215 ↗
• MalfunctionNov 8, 2018Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK WITH A NON-MEDTRONIC 6F SHEATH AND SPIDER FX TO TREAT A MODERATELY CALCIFIED LESION SHAVING IN STENT IN THE SUPERFICIAL FEMORAL ARTERY(SFA). IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THERE WERE NO ISSUES NOTED WITH DEVICE PRIOR TO USE. IT WAS REPORTED THAT THE DEVICE BROKE IN HALF UPON REMOVING IT FROM THE SHEATH. NO COMPONENT EMBOLISED IN THE PATIENT. THE PROCEDURE WAS FINISHED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. NO DEFORMATION OF THE CUTTER WAS NOTED. NO DAMAGE TO THE STENT WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050065 ↗
• MalfunctionOct 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DEVICE TO TREAT A SOFT TISSUE LESION WITH A CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION LENGTH AND ARTERY DIAMETER WERE 200MM AND 7MM RESPECTIVELY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE NOSE CONE BROKE OFF WHERE THE CATHETER MEETS THE NOSECONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969867 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE THE TURBOHAWK WITH A 7FR NON-MDT SHEATH AND A .014 GUIDEWIRE TO TREAT A SOFT PLAQUE CTO, IN THE LEFT SUPERFICIAL FEMORAL ARTERY AS PER IFU. THE VESSEL WAS PRE AND POST DILATED, NO RESISTANCE ENCOUNTERED DURING THE PROCEDURE. IT WAS REPORTED DURING THE PROCEDURE THE CATHETER TIP DETACHED AT THE HINGE PIN FROM THE BLACK CATHETER. THE DRIVE SHAFT INSIDE WAS LEFT INTACT AND KEPT THE CATHETER TIP FROM EMBOLIZING. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7721608 ↗
• MalfunctionJul 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A TURBOHAWK WITH A PROTEGE AND USING A 7FR COOK ANSEL SHEATH AND 0.14 300 COOK ROADRUNNER GUIDEWIRE TO TREAT A SEVERELY CALCIFIED 5-6MM X 40-50MM LESION WITH SEVERE TORTUOSITY AND WITH 80-90% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY. A STEEP AORTIC BIFURCATION WAS REPORTED AS ABNORMAL IN RELATION TO THE PATIENTS ANATOMY. BOTH DEVICES WERE PREPPED AS PER THE IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. NO ISSUES OR DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE TRAY.IT WAS REPORTED THE TURBOHAWK WOULD NOT ADVANCE THROUGH SHEATH OVER THE STEEP AORTIC BIFURCATION DESPITE REPOSITIONING AND RE-ADVANCEMENT. UPON REMOVAL OF TURBOWHAWK AN IRREGULARITY AT DISTAL TIP BETWEEN METAL AND CATHETER WAS OBSERVED AND A NEW DEVICE WAS USED IN THE PROCEDURE. A HAWK-1 M WAS ADVANCED, CROSSED, AND UTILIZED WITHOUT DIFFICULTY. THE PHYSICIAN REPORTED THAT THE PROTÉGÉ FAILED TO CROSS THE TARGETED LESION. IT WAS REPORTED THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. THE LESION WAS TREATED WITH FURTHER PRE-DILAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662081 ↗
• MalfunctionMay 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE FOR TREATMENT OF A MODERATELY CALCIFIED PLAQUE 70% STENOSED 160MM LESION IN THE PATIENTS MID/DISTAL SUPERFICIAL FEMORAL ARTERY(SFA)/POPLITEAL ARTERY(PA). LITTLE TORTUOSITY WAS REPORTED AND A VESSEL DIAMETER OF 5-6MM WAS NOTED. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND USED WITHOUT ISSUE. THE TURBOHAWK WAS ABLE TO OPEN AND CLOSE THE CUTTER BUT THE CUTTER COULD NOT BE PUSHED INTO THE HOUSING. STRONG RESISTANCE WAS ENCOUNTERED WHEN THE THUMBSWITCH WAS PUSHED FORWARD. THE THUMBSWITCH NEEDED TO BE PUSHED SEVERAL TIMES TO CUT THE PLAQUE BUT THE CUTTER COULD NOT COMPLETELY ENTER THE HOUSING. THE DEVICE WAS REMOVED SUCCESSFULLY, AND PHYSICIAN CHECKED THAT THERE WERE NO HINDERANCE FROM FOREIGN BODIES. WHEN THE DEVICE WAS TAKEN OUT, THE HEAD OF THE CUTTER WAS RECOVERED PARTLY. THE DEVICE WAS REPLACED WITH ANOTHER TURBOHAWK AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548152 ↗
• MalfunctionMar 23, 2018Device Inoperable; Device Operates Differently Than Expected; Device Inoperable; Device Operates Differently Than Expected

  THE PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS REPORTED TO BE SLIGHTLY TORTUOUS. IT WAS REPORTED THAT THE CUTTER WOULD NOT CLOSE AND WAS JAMMED WHEN TRYING TO ADVANCE THE THUMBSWITCH. THE TECHNICIAN EXPLAINED THAT THE CUTTER THUMB SWITCH WOULD NOT ADVANCE FORWARD WHEN TRYING TO CLOSE THE CUTTER INSIDE PATIENT. THE BLADE JAMMED AND WOULD NOT CLOSE WHILE IN USE IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION NOTED IN THE CUTTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366069 ↗
• MalfunctionNov 9, 2017Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  PHYSICIAN INTENDED TO USE A TURBOHAWK DIRECTIONAL ATHETERCTOMY DEVICE WITH A 8FR SHEATH AND 0.014¿ GUIDEWIRE FOR THE TREATMENT OF A LESION IN PROXIMAL LOCATION OF THE SUPERFICIAL FEMORAL ARTERY/ POPLITEAL ARTERY/ TIBIAL/POPLITEAL TRUNK OF MODERATE TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUE NOTED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED WITH FLUSHING TISSUE DURING THE PROCEDURE. IT WAS REPORTED THAT AFTER FLUSHING THE DEVICE MORE THAN 10 TIMES, THE BLADE STILL COULD NOT MOVE. THE PHYSICIAN POST-DILATED THE LESION BY PTA BALLOON TO COMPLETE THE PROCEDURE. OPERATION WAS EXTENDED FOR 1.5 HOURS DUE TO THE REPLACEMENT OF DEVICE. NO PATIENT INJURY REPORTED. PATIENT¿S STATUS WAS REPORTED TO BE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7016509 ↗
• MalfunctionSep 29, 2017Break; Material Distortion; Break; Material Distortion

  PHYSICIAN WAS USING A TURBOHAWK ATK DEVICE FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). NO LESION INFORMATION PROVIDED. SHEATH SIZE AND BRAND UNKNOWN AND UNKNOWN IF EMBOLIC PROTECTION WAS USED. ISSUE WAS GUIDEWIRE PROLAPSE. IT IS UNKNOWN IF THE DEVICE WAS PUSHED OVER THE BIFURCATION. THE GUIDEWIRE WAS FLUSHED. UNKNOWN RESISTANCE WAS FELT WHEN DELIVERING THE DEVICE. IT IS UNKNOWN IF THE TIP WAS DAMAGED OR CAUSED EMBOLISM. THE PROCEDURE WAS COMPLETED BY IMPLANTATION OF ONE STENT. UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906566 ↗
• MalfunctionSep 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PHYSICIAN INTENDED TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A LESION IN THE SFA WITH 70% STENOSIS. THE LESION EXHIBITED SEVERE CALCIFICATION AND TORTUOSITY. IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN WAS UNABLE TO OPEN THE CUTTER HEAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111723. One submission often covers many models, so check the product and lot details in each record.

• Z-3022-2018 · Aug 10, 2018 · Terminated
  ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.