TurboHawk™ THS-SX-C (UDI 00643169968226)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169968226), received between Feb 28, 2019 and Jan 9, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION RECEIVED. PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK BTK ATHERECTOMY DEVICE DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THE TIP DETACHED. SURGICAL INTERVENTION WAS REQUIRED TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473159 ↗
• InjuryNov 16, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY ALONG WITH 6FR SHEATH AND NITREX GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION WITH SOFT TISSUE IN THE LEFT PROXIMAL TO MID TIBIAL/POPLITEAL TRUNK (TPT), POSTERIOR TIBIAL ARTERY (PTA) AND ANTERIOR TIBIAL ARTERY (ATA) WITH 75% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3MM AND 5MM - 10MM RESPECTIVELY. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. DURING ADVANCEMENT, MODERATE RESISTANCE WAS FELT AND THE TIP DETACHED BUT DID NOT SEPARATE AT THE HINGE PIN. IT WAS REPORTED THAT ACCESS WAS PEDAL APPROACH USING A 6FR SLENDER SHEATH. AFTER TREATING ATA USING ATHERECTOMY IN A RETROGRADE FASHION, ATTEMPTING TO TREAT PTA WHICH WAS DONE WITH TWO PASSES, AT THE THIRD ATTEMPT, FELT RESISTANCE, NOTICED THE TIP OF THE DEVICE DETACHED, REMAINING IN PTA AS THE DEVICE WAS REMOVED FROM THE BODY. PHYSICIAN GAINED PTA ACCESS, USED AN ENDOVASCULAR GRASPER ALLIGATOR BEING ABLE TO REMOVE THE ENTIRE TIP, LEAVING NO FOREIGN BODY IN THE ARTERY. AFTERWARDS, SHEATHS WERE REMOVED AND CLOSED USING A 4-0 MONOCRYL SUTURE. PROCEDURE WAS COMPLETED IN A SAFE F

  Patient problems: Insufficient Information

  MAUDE report 12820105 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A TURBOHAWK FOR PATIENT TREATMENT ON THE RIGHT, MID SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS FIBROUS AND HAD LITTLE TORTUOSITY WITH NO DEGREE OF CALCIFICATION. A NON-MEDTRONIC 6 FR SHEATH AND NON-MEDTRONIC 0.014" GUIDEWIRE. IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED. IT WAS REPORTED THAT THE NOSECONE SEPARATED FROM THE CATHETER AFTER ATHERECTOMY OUTSIDE OF THE PATIENT BODY DURING FLUSHING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311772 ↗
• MalfunctionAug 4, 2021Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY ALONG WITH NON-MEDTRONIC 6FR 55CM SHEATH, GUIDEWIRE AND 4MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT MID TIBIAL/POPLITEAL TRUNK TO POPLITEAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS A LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3.5MM AND 60MM RESPECTIVELY. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CUTTER DETACHED FROM THE NOSECONE. WHAT COULD HAVE CAUSED THE ISSUE WAS THE STRESS OF HAVING A BUDDY SPIDER WIRE, WHICH WAS STATED NOT RECOMMENDED. AT ONE POINT THE SPIDER WIRES (LOT #: B078329) CROSSED CAUSING STRESS ON THE TIP AND CUTTER. DEVICE SUCCESSFULLY TREATED THE PERONEAL, AFTER PTA OF PT, DECIDED TO TRY HAWK IN THAT ARTERY TOO. IT WAS NOTICED ON FLUOROSCOPY THE DETACHMENT AND RETRIED THE TURBOHAWK CATHETER SUCCESSFULLY. THE CUTTER STAYED ATTACHED TO THE CATHETER SO THE PHYSICIAN WAS ABLE TO SAFELY REMOVED THE CUTTER FOLLOWING DETACHMENT. NO INTERVENTION WAS REQUIRED FOR DEVICE REMOVAL. THE DEVICE WAS SAFELY REMOVED. THERE WAS NO VESSEL DAMAGE NOTED. DEVICE WAS THROWN AWAY PHYSICIAN REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272776 ↗
• MalfunctionMay 21, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED A TURBOHAWK ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 200MM FIBROUS AND PLAQUE LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (PA). SLIGHT VESSEL TORTUOSTY IS REPORTED. LESION EXHIBITED 77% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS USED AS NORMAL SUCCESSFULLY, BUT IT IS REPORTED THE NOSECONE DETACHED OFF THE DEVICE UPON REMOVAL FROM THE PATIENT. THE PHYSICIAN CONTINUED WITH PLANNED DRUG-COATED BALLOON ANGIOPLASTY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862040 ↗
• MalfunctionAug 26, 2020Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID AND PROXIMAL POPLITEAL ARTERY AND TIBIAL/POPLITEAL TRUNK. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION WAS REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE DEVICE. NO EMBOLIC PROTECTION WAS USED. IT IS REPORTED MODERATE RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL. IT WAS DESCRIBED THAT THERE WAS A NODULE COMING OUT THE SIDE OF NOSECONE WHICH CAUSED IT TO BEND THE TIP. IT WAS DESCRIBED AS LOOKING LIKE A LARGE AND HARD BUBBLE OF PLAQUE. THE TECOTHANE JACKET WAS NOT OBSERVED TO BE TORN. THERE WAS RESISTANCE FELT WHEN REMOVING THE DEVICE. THE CUTTER WAS INSIDE THE HOUSING DURING DEVICE REMOVAL. THERE WAS NO VESSEL DAMAGE NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452690 ↗
• MalfunctionMar 23, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN USED A TURBOHAWK DEVICE DURING TREATMENT A PLAQUE LESION IN THE PATIENT¿S MID TIBIAL/POPLITEAL TRUNK. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IT IS REPORTED DURING THE PROCEDURE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THE CUTTER ON THE DEVICE WAS DAMAGED. NO PIECES OR CHIPS WERE MISSING FROM THE CUTTER. THE CUTTER WAS LOCATED INSIDE THE HOUSING UPON DEVICE REMOVAL. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE WAS NOTED. IT IS REPORTED THAT A SMALL PIECE OF WIRE WAS REMOVED FROM THE DEVICE WITH A PAIR OF TWEEZERS. A NEW DEVICE WAS OPENED. NO COMPLICATIONS WERE REPORTED FROM THE DEFECTIVE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864347 ↗
• MalfunctionJan 17, 2020Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Difficult to Advance; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Difficult to Advance

  THE PHYSICIAN ATTEMPTED TO USE A TURBOHAWK DEVICE WITH NON-MEDTRONIC .014¿ GUIDEWIRE AND 6F SHEATH TO TREAT A 40MM CALCIFIED LESION IN THE PATIENTS LEFT MID POPLITEAL ARTERY. VESSEL DIAMETER IS REPORTED AS 5MM. MODERATE DEGREE OF CALCIFICATION AND MODERATE DEGREE OF TORTUOSITY REPORTED. THE IFU WAS FOLLOWED. SIZE 4 SPIDER EMBOLIC PROTECTION WAS USED. THE VESSEL WAS POST-DILATED. RESISTANCE WAS FELT DURING ADVANCEMENT, TIP WAS DAMAGED AND WOULD NOT ALLOW DEVICE TO ADVANCE OVER THE GUIDE WIRE. IT WAS REPORTED THAT THE TIP SEPARATED AT THE HINGE PIN. THE PROCEDURE WAS COMPLETED USING ANOTHER TURBOHAWK AND A NANOCROSS BALLOON. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601129 ↗
• InjurySep 16, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY ALONG WITH NON MEDTRONIC 6FR SHEATH AND GUIDE WIRE TO TREAT A LITTLE CALCIFIED LESION IN THE COMMON ILIAC ARTERY. THE VESSEL IS SEVERELY TORTUOUS WITH A DIAMETER OF 7MM. THE VESSEL WAS PRE DILATED BUT NOT POST DILATED. IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT DURING WITHDRAWAL, MINIMAL RESISTANCE WAS ENCOUNTERED AND THE TIP SEPARATED AT HINGE PIN (NOSE CONE). THERE WAS NO GUIDE WIRE PROLAPSE. IT WAS REPORTED THAT THE NOSE CONE WAS COMPLETELY REMOVED FROM THE SHAFT OF THE CATHETER. THE NOSE CONE WAS STENTED (CAGED) INTO THE ILIAC ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9071053 ↗
• InjuryJul 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED A TURBOHAWK DEVICE WITH A NON-MEDTRONIC 6FR SHEATH AND A 0.014 300CM NITREX WIRE TO TREAT A 150MM PLAQUE, 90% STENOTIC LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS REPORTED AS 6MM WITH SEVERE TORTUOSITY. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT THE ATHERECTOMY WAS PERFORMED. THE PHYSICIAN ENCOUNTERED HIGH RESISTANCE WHILE ATTEMPTING TO REMOVE THE DEVICE. AFTER 2/3 ATTEMPTS, THE DEVICE WAS REMOVED. AFTER INSPECTION, IT WAS NOTICED THAT THE NOSECONE WAS DETACHED. ATTEMPTS TO RETRIEVE IT WITH A SNARE WERE UNSUCCESSFUL SO THE PHYSICIAN DECIDED TO CAGE THE NOSECONE WITH A SELF-EXPANDING STENT. THE VESSEL WAS POST DILATED. THE PHYSICIAN WAS SATISFIED WITH THE ANGIOGRAPHIC RESULTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8788596 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING ATURBOHAWK TO TREAT A PLAQUE LESION WITH 50% STENOSIS IN THE DISTAL TIBIAL/POPLITEAL TRUNK. IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. NO RESISTANCE WAS FELT. IT WAS REPORTED THAT THE TIP OF THE DEVICE DETACHED AND THE DAMAGE WAS DESCRIBED AS ¿BLACK LINE WAS COMING OFF¿. THE TIP DID NOT SEPARATE AT THE HINGE PIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8481966 ↗
• InjuryFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A TURBOHAWK DEVICE TO TREAT A 5MM MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT COMMON ILIAC ARTERY. SEVERE TORTUOSITY WAS REPORTED IN THE 8MM DIAMETER ARTERY AND STEEP BIFURCATION. A 6 X 45 NON-MEDTRONIC SHEATH AND AN 0.014 NON-MEDTRONIC GUIDEWIRE WAS USED. THE IFU WAS FOLLOWED AND THE GUIDEWIRE WAS HYDRATED DURING PREP. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. IT WAS REPORTED THAT DURING THE PROCEDURE MODERATE RESISTANCE WAS FELT DURING BOTH ADVANCEMENT AND WITHDRAWAL OF THE DEVICE. THE GUIDEWIRE LOCKED UP ON THE CATHETER AND THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. THE FLUSH PORT ON THE CATHETER HANDLE WAS NOT DAMAGED. THERE WAS DAMAGE TO THE TIP AND THE TIP OF THE DEVICE DETACHED. THE TIP OF THE DEVICE REMAINED IN THE PATIENT AND WAS CAGED TO THE WALL OF THE ILIAC USING A VISIPRO STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8377243 ↗