TurboHawk™ THS-LX-C (UDI 00643169968400)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169968400), received between Dec 11, 2018 and Jan 13, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE WITH A SPIDER FX EMBOLIC PROTECTION DEVICE AND 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A PLAQUE AND SOFT TISSUE LESION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. IT IS REPORTED RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICES AND IT IS REPORTED THE NOSECONE DETACHED FROM THE DRIVESHAFT OF THE TURBOHAWK DEVICE. THE SPIDER FX IS REPORTED TO HAVE BECOME DAMAGE DURING WITHDRAWAL. THE DEVICES WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163266 ↗
• MalfunctionJun 26, 2019Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DEVICE TO TREAT A CALCIFIED LESION WITH MODERATE TORTUOSITY, SEVERE CALCIFICATION AND 90% STENOSIS IN THE RIGHT PROX, MID, DISTAL SFA (SUPERFICIAL FEMORAL ARTERY). IT WAS NOTED THAT IT WAS A DIFFICULT ILIAC ARCH. DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THERE WAS DIFFICULTY CLOSING THE DEVICE AFTER THE SECOND PASS DOWN THE SFA. IT WAS REPORTED THE THUMBSWITCH TURNED OFF WITH DIFFICULTY, THE PHYSICIAN FELT THAT IT WAS NOT COMPLETELY CLOSED. THE DEVICE STOPPED FUNCTIONING AND WAS SAFELY REMOVED FROM THE PATIENT. THE CUTTER WAS POSITIONED INSIDE THE HOUSING. ON REMOVAL FROM THE PATIENT, DEFORMATION WAS OBSERVED ON THE CUTTER, ALL CUTTER COMPONENTS WERE INTACT. THE SHEATH WAS REINSERTED AND THE PROCEDURE WAS COMPLETED WITH BALLOON AND STENTING. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE PRODUCT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734070 ↗
• InjuryApr 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE TORTUOSITY WAS REPORTED IN THE VESSEL. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERFORATED VESSEL DUE TO THE LESION BEING CALCIFIED. THE PHYSICIAN USED A BALLOON TO TREAT THE PERFORATION. DURING CLEANING OF THE DEVICE, A SECOND TIME IN PREPARATION TO USE IT AGAIN IN THE PATIENT, THE SHAFT OF THE DEVICE BROKE AND DETACHED AT THE HUB. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500110 ↗
• MalfunctionJan 7, 2019Mechanical Problem; Mechanical Problem

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK TO TREAT A FIBROUS LESION WITH 100% STENOSIS IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED. IT WAS REPORTED THAT THE DEVICE COULD NOT PACK INSIDE THE PATIENT BUT IT MOVED FREELY OUTSIDE THE PATIENT¿S BODY PRIOR TO PLACING INTO THE PATIENT. THE PACKER WOULD NOT ADVANCE AFTER THE SECOND PACKING STAGE AND THE DEVICE WAS FULL. THE PHYSICIAN CANNOT CONFIRM IF IT CORRECTLY PACKED DURING FIRST PASS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8222631 ↗
• MalfunctionDec 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A TURBOHAWK WITH A SPIDER FX AND A NON-MEDTRONIC SHEATH (7 X 45/TERUMO) TO TREAT A SEVERELY CALCIFIED LESION PRESENTING CTO (CHRONIC TOTAL OCCLUSION 100%) IN THE MID-RIGHT CALCIFIED COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. THE VESSEL PRESENTED MINIMAL TORTUOSITY. ARTERY LENGTH AND DIAMETER WERE 6 MM AND 30 MM, RESPECTIVELY. IFU WAS FOLLOWED. MODERATE RESISTANCE WAS FELT UPON WITHDRAWAL. IT WAS REPORTED THAT THE NOSECONE DETACHED AT THE HINGE PIN WHEN PULLING THE DEVICE BACK THROUGH THE SHEATH. GUIDEWIRE PROLAPSE AND A TORN OR RIPPED LUMEN WAS ALSO REPORTED. IN ORDER TO REMOVE THE NOSECONE, THE SPIDER WAS PULLED BACK INTO THE SHEATH, WHERE THE NOSECONE WAS TRAPPED. THE PROCEDURE WAS COMPLETED USING A NEW 6 MM SPIDER AND TURBOHAWK. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149970 ↗