TurboHawk™ THS-LS-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00821684065785), received between Jul 7, 2017 and Mar 13, 2020 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.

• MalfunctionMar 13, 2020Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6 MM. SEVERE VESSEL CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE CATHETER JAMMED WITH THE FILTER. THIS OCCURRED WHEN THE PROCEDURE WAS ALMOST FINISHED. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT SAFELY AND WITHOUT INJURY. NO PATIENT INJURY REPORTED.

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

  MAUDE report 9828128 ↗
• InjuryOct 3, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  PHYSICIAN WAS USING A TURBOHAWK DIRECTIONAL ATHERECTOMY TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL COMMON ILIAC ARTERY AND SFA WITH CHRONIC TOTALLY OCCLUDED (CTO-100%). THE VESSEL AND LESION LENGTH ARE 6MM AND 40MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED AND IFU PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE DEVICE BROKE, ANGIOGRAPHY SHOWED WIRE WRAP. THE DEVICE AND WIRE WAS THEN ATTEMPTED TO BE REMOVED. THE TIP SEPARATED IN THE WIRE KNOT. THE DEVICE WHICH WAS DAMAGED CAUSED THE 7FR SHEATH TO COME OUT. THE PATIENT WAS THEN TRANSPORTED TO HOSPITAL FOR SURGERY. A FEMORAL ENDARTECTOMY WAS PERFORMED WITH THE WIRE AND HAWK TIP REMOVED.

  Patient problems: Injury

  MAUDE report 9150195 ↗
• MalfunctionAug 28, 2019Mechanical Problem; Positioning Problem; Mechanical Problem; Positioning Problem

  PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE DURING TREATMENT OF A CALCIFIED/PLAQUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED DURING THE PROCEDURE THE DEVICE COULD NOT BE ADVANCED. THE REMOVAL OF THE COLLECTION CHAMBER WAS FOUND TO BE DAMAGED AND IT IS REPORTED THAT THE NOSECONE WAS RUPTURED. THE DEVICE WAS REPLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939880 ↗
• MalfunctionJul 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A TURBOHAWK ATK DEVICE TO TREAT A FIBROUS, CALCIFIED, PLAQUE LESION IN THE PATIENT¿S MID POPLITEAL ARTERY. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT THE NOSECONE DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797504 ↗
• MalfunctionJul 16, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A TURBOHAWK ATK WITH A NON-MEDTRONIC (ABBOTT) 0.014 GUIDEWIRE DURING TREATMENT OF A 40MM PLAQUE CALCIFIED 70% STENOTIC LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5MM. NO TORTUOSITY ALONG WITH MODERATE CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED AND THE DEVICE DURING PREP. IT WAS REPORTED THAT THE DEVICE JAMMED DURING PREP AND WOULD NOT CLOSE. THE THUMBSWITCH WAS UNABLE TO OPEN AND CLOSE THE CUTTER. NO DEFORMATION OR DAMAGE WAS NOTED TO THE TIP. MOTOR ISSUES WERE EXPERIENCED WHEN ATTEMPTED TO BE TURNED ON AND OFF. DEVICE NOT USED IN PATIENT. NO ALLEGATION NOTED WITH SPIDER FX DEVICE MENTIONED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IT WAS NOTED TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793664 ↗
• MalfunctionMar 7, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A PLAQUE MODERATELY CALCIFIED, MODERATELY TORTUOS, 70% STENOTIC LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY(SFA). ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 5MM - 6MM, RESPECTIVELY. THE LESION WAS NOT PRE-DILATED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED FOR THE PROCEDURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT HOWEVER, RESISTANCE WAS ENCOUNTERED ON ADVANCING THE DEVICE TO THE LESION. THERE WAS NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE POST DEPLOYMENT OF THE STENT. IT WAS REPORTED THAT THE DELIVERY CATHETER BECAME CAUGHT ON THE STENT UPON WITHDRAWAL. SOME OF THE STENT BECAME STUCK BUT THE REMAINING PART OF THE STENT WAS REMOVED. THE PHYSICIAN THEN TOOK A TURBOHAWK ATK DEVICE ALONG WITH A 7FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE AND A 6MM EMBOLIC PROTECTION DEVICE. THE CUTTER HEAD WAS UNABLE TO BE PUSHED TO TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8399331 ↗
• MalfunctionFeb 1, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A TURBOHAWK ATK DEVICE TO TREAT A 60% STENOTIC, CALCIFIED PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY(SFA). NO TORTUOUSITY WAS REPORTED. THE DEVICE WAS PREPED AS PER IFU AND INSPECTED WITH NO ISSUES IDENTIFIED. THE PHYSICIAN CARRIED OUT THE FIRST CUT BUT THE CUTTER HEAD COULD NOT RETURN TO THE HOUSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296197 ↗
• InjuryDec 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK WITH A SPIDER FX, 8FR SHEATH AND 0.014 GUIDEWIRE FOR TREATMENT OF A SEVERELY CALCIFIED PLAQUE LESION WITH 80-90% STENOSIS IN THE PATIENTS PROXIMAL MID AND DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY AND MODERATE TORTUOSITY WAS REPORTED. IFU WAS FOLLOWED AND DEVICES WERE PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. AFTER CUTTING WAS COMPLETED WITH THE TURBOHAWK, THE PHYSICIAN ATTEMPTED TO WITHDRAW BOTH DEVICES BUT RESISTANCE WAS ENCOUNTERED AS THE SPIDER GUIDEWIRE WAS ENTANGLED WITH THE TURBOHAWK CUTTER. ATTEMPTS WERE MADE FOR REMOVAL BUT BOTH THE SPIDER FILER AND TURBOHAWK NOSE CONE DETACHED IN THE VESSEL AND COULD NOT BE RETRIEVED. THE PATIENT WAS SENT FOR SURGERY TO SUCCESSFULLY REMOVE THE DETACHED PIECES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8145760 ↗
• InjuryNov 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A TURBOHAWK DEVICE WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 70MM, 90% STENOSED MODERATELY CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5MM. VESSEL DESCRIBED AS BEING NON-TORTUOUS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. IT IS REPORTED DURING WITHDRAWAL OF THE DEVICE FOLLOWING SECOND ADVANCEMENT, SEVERE RESISTANCE WAS FELT, AND THE TIP SEPARATED AT THE HINGE PIN. THE TIP IS REPORTED TO HAVE EMBOLISED AT THE TARGET LESION. IT HAS BEEN REPORTED THE TIP WAS ¿PULLED OUT OF THE BODY NORMALLY¿. A VESSEL DISSECTION WAS ALSO REPORTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Embolism

  MAUDE report 8099791 ↗
• MalfunctionJan 26, 2018Device Operational Issue; Device Operational Issue

  THE PHYSICIAN HAD ATTEMPTED TO USE A TURBOHAWK ATHERECTOMY DEVICE TO TREAT A 10CM SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA) AND POPLITEAL ARTERIES (80% STENOSIS). THE ARTERIES HAD MODERATE TORTUOSITY AND THE SFA HAD A DIAMETER OF 4-5MM. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE OPERATED CORRECTLY AT THE BEGINNING OF THE PROCEDURE. IT WAS REPORTED AFTER A PASS THROUGH CALCIFICATION THE CUTTER DRIVER LOCKED, COULD NO LONGER PACK AND THE CUTTER WAS UNABLE TO RETURN INTO THE HOUSING. THE TURBOHAWK WAS REMOVED FROM THE BODY AND THE CUTTER DRIVER WORKED NORMALLY. AN ATTEMPT WAS MADE TO USE THE DEVICE TO TREAT THE LESION AGAIN AND THE SAME ISSUE RECURRED. BALLOON DILATION WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7220982 ↗
• MalfunctionOct 11, 2017Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHETERCTOMY DEVICE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT SFA. THE ARTERY WAS 6 MM. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. PATIENT HAD RECEIVED VERSED AND FENTANYL FOR CONSCIOUS SEDATION. IT WAS REPORTED THAT AFTER SUCCESSFULLY PERFORMING THE ATHETERCTOMY PROCEDURE, IT WAS NOTED THAT THE TRIGGER ON THE DEVICE WOULD NOT CLOSE. WHILE MOVING THE DEVICE AND HOLDING PRESSURE ON THE TRIGGER, "AN AUDIBLE POP" WAS HEARD AND FELT ON THE DEVICE WHILE THE DISTAL END OF THE CATHETER WAS IN THE SHEATH. THE CUTTER AND THE NOSECONE WERE BOTH DISLODGED FROM THE MAIN CATHETER WITH THE CUTTER BEING STUCK IN THE CUTTER WINDOW. IT WAS DISCOVERED THE NOSECONE WAS DETACHED AFTER REMOVAL FROM THE PATIENT. AN UNKNOWN STENT WAS REPORTED TO BE DEPLOYED IN THE LESION AFTER ATHETERCTOMY, FOLLOWED BY A POST-DILATION USING A 6MM UNKNOWN BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT INJURY WAS REPOR TED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943121 ↗
• MalfunctionAug 18, 2017Device Packaging Compromised; Device Packaging Compromised

  PHYSICIAN USED OF A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE FOR THE TREATMENT OF CALCIFIED LESION IN AN UNKNOWN VESSEL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF CATHETER SEPARATED FROM THE DEVICE. THE PHYSICIAN RETRIEVED IT AND TRIED TO REMOVE TISSUE FROM THE NOSECONE. WHEN THE PHYSICIAN SAFELY TRIED TO RE-INSERT THE DEVICE AGAIN, THE END OF THE CATHETER WAS SEPARATED. THE PROCEDURE WAS THEN COMPLETED WITH A NEW TURBOHAWK DEVICE OF SAME MODEL. THERE WAS NO PATIENT IMPACT AND THE PATIENT WAS REPORTED AS BEING STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6805568 ↗
• MalfunctionJul 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE WAS USED FOR THE TREATMENT OF A MODERATELY CALCIFIED, NON-TORTUOUS LESION IN LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, WHICH EXHIBITED 80% STENOSIS. IT IS REPORTED THAT THE ILIAC ARTERIES HAD SEVERE TORTUOSITY. DEVICE WAS PREPPED WITHOUT ISSUE. IFU WAS FOLLOWED. IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE DEVICE AND THE DEVICE TIP BROKE BECAUSE OF FORCED REMOVAL FROM SHEATH. THE TIP DID REMAIN PARTIALLY ATTACHED TO THE CATHETER. THE REMAINDER OF THE PROCEDURE WAS PERFORMED WITHOUT ANY ADDITIONAL NEED FOR FURTHER ATHERECTOMY USING STANDARD BALLOON ANGIOPLASTY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693409 ↗

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.