TurboHawk™ THS-SS-CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169968202), received between May 24, 2019 and Jan 30, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2023Material Deformation; Material Deformation

  A PHYSICIAN WAS USING A TURBOHAWK FOR THE TREATMENT OF AN 80MM FIBROUS PLAQUE LESION IN THE DISTAL REGION OF THE PEDAL ARTERY. THERE WAS MODERATE TORTUOSITY AND CALCIFICATION. THE IFU WAS FOLLOWED. A NON MEDTRONIC GUIDEWIRE AND SHEATH WAS USED. THE DEVICE WAS NOT ADVANCED OVER BIFURCATION. THE GUIDEWIRE WAS HYDRATED DURING PREPARATION. NO RESISTANCE FELT. IT WAS REPORTED THAT THE WIRE LUMEN PULLED APART (GUIDEWIRE ADVANCEMENT/ LOCK-UP/ PROLAPSE/ LUMEN TORN/ RIPPED). THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. THE GUIDEWIRE PROLAPSE DID NOT CAUSE TIP DAMAGE OR EMBOLIZATION DURING PROCEDURE. THE GUIDEWIRE DID NOT LOCK UP ON THE CATHETER. A KINK WAS OBSERVED IN THE DISTAL 1/3 OF THE GUIDEWIRE. THE TECH WAS INSTRUCTED TO PIN THE WIRE VERY WELL AND WITH THE DIFFICULTY OF ADVANCING THE DEVICE TOO MUCH FORCE ON THE DEVICE WAS EXPERIENCED. THE DEVICE WAS WITHDRAWN FROM THE BODY AND THE ARTERY WAS POST DILATED. THE TIP DID NOT DETACH. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263158 ↗
• InjuryDec 7, 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 TURBOHAWK DIRECTIONAL ATHERECTOMY ALONG WITH A NON-MEDTRONIC 7FR SHEATH, 0.014" SPIDER FX GUIDEWIRE AND 4.0MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (POP). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 4CM RESPECTIVELY. THE LESION WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT DURING WITHDRAWAL MINIMAL RESISTANCE WAS ENCOUNTERED AND TIP DETACHED BUT DID NOT SEPARATE AT THE HINGE PIN. THE NOSE CONE BECAME DETACHED IN THE SHEATH UPON REMOVAL OF THE DEVICE AFTER USE. PHYSICIAN BELIEVES THERE WAS AN ISSUE WITH THE SHEATH THAT CAUSED THE DETACHMENT A LARGER SPIDER 7.0MM AND SNARE WERE USED IN COMBINATION TO RETRIEVE THE DETACHED NOSE CONE AND NO HARM WAS CAUSED TO THE PATIENT. THE IVUS CATHETER USED DURING PROCEDURE WAS ALSO DAMAGED IN THE SHEATH. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12948427 ↗
• InjurySep 10, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 6-8MM SOFT TISSUE LESION IN THE PATIENT¿S MID RIGHT TIBIAL/ POPLITEAL TRUNK. VESSEL DIAMETER REPORTED AS 2-4MM. MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. THE GUIDEWIRE WAS HYDRATED AT PREP. VESSEL PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. IT IS REPORTED THAT MINIMAL RESISTANCE WAS NOTED DURING INITIAL ADVANCEMENT AND THE DEVICE WAS UNABLE TO CROSS AND ENCOUNTERED RESISTANCE WITH THE GUIDEWIRE. THE GUIDEWIRE IS REPORTED TO HAVE LOCKED UP ON THE CATHETER. TIP DAMAGE IS REPORTED TO HAVE OCCURRED. A SNARE RETRIEVAL DEVICE WAS USED USING CONTRALATERAL ARTERIAL ACCESS TO REMOVE THE DEVICE SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514228 ↗
• MalfunctionJun 30, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC SHEATH AND SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF AN 80MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL RIGHT TIBIAL/POPLITEAL TRUNK AND PERONEAL ARTERY. MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. VESSEL DIAMETER REPORTED AS 4MM. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED THAT 3 PASSES WERE MADE WITH THE DEVICE AND THE PHYSICIAN BEGAN TO WITHDRAW THE DEVICE OVER THE SPIDER WIRE. IT IS REPORTED RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN THEN CHECKED THE SPIDER POSITION DISTALLY AND AT THE DISTAL END OF THE SHEATH. IT WAS FOUND THE SPIDER FX WIRE HAD PROLAPSED. THE PHYSICIAN ATTEMPTED TO STRAIGHTENED OUT THE WIRE, BUT A DETACHMENT OCCURRED ON THE TURBOHAWK. THE TIP SEPARATED AT THE HINGE PIN. THE PHYSICIAN REMOVED THE CATHETER AND THEN USED A SNARE TO RETRIEVE THE DETACHED REMAINING NOSE CONE AND SPIDER WIRE. THE PHYSICIAN THEN RE-CROSSED THE LESION AND USED A NANOCROSS FOR POST-DILATION. NO FURTHER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211279 ↗
• InjuryNov 27, 2019Difficult to Remove; Detachment of Device or Device Component; Compatibility Problem; Physical Resistance/Sticking; Difficult to Remove; Detachment of Device or Device Component; Compatibility Problem; Physical Resistance/Sticking

  PHYSICIAN USED A TURBOHAWK DIRECTIONAL ATHERECTOMY ALONG WITH A NON MEDTRONIC 6FR SHEATH AND A MEDTRONIC 0.014 GUIDE WIRE IN PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL POSTERIOR TIBIAL ARTERY WITH 90% STENOSIS. THE VESSEL IS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3 MM AND 80 MM RESPECTIVELY. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. DURING WITHDRAWAL THERE WAS MODERATE RESISTANCE FELT AND TIP DAMAGED, THE TIP BROKE WHERE IT WAS TWISTED FOR CLEANING. IT WAS REPORTED THAT AFTER ATHERECTOMY WAS PERFORMED IN THE LEFT PTA AND THE DEVICE WAS BEING REMOVED, PHYSICIAN NOTICED RESISTANCE WITH THE DEVICE WITH ENTERING THE 6FR CROSSOVER SHEATH. PHYSICIAN NOTICED A PROLAPSE IN THE .014 NITREX GUIDE WIRE. AFTER STRAIGHTENING THE WIRE, DEVICE ENTERED THE SHEATH. UPON REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THE TIP OF THE NOSECONE WAS NOT PRESENT ON THE DEVICE. PHYSICIAN LOOKED AT THE END OF THE SHEATH UNDER THE MAGNIFIED FLUOROSCOPY AND SAW THE TIP STILL ON THE WIRE. THERE WAS A STENOSIS THAT WAS GOING TO BE STENTED DURING PROCEDURE, PHYSICIAN DECIDED TO STENT TH

  Patient problems: Injury

  MAUDE report 9383458 ↗
• MalfunctionNov 22, 2019Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking

  PHYSICIAN WAS USED A TURBOHAWK DIRECTIONAL ATHERECTOMY TO TREAT A SEVERELY CALCIFIED, LITTLE TORTUOUS LESION IN THE MID SFA WITH 85% STENOSIS. THE LESION WAS NOT PRE DILATED BUT POST DILATED. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE TIP DETACHED DURING REMOVAL OF THE ATHERECTOMY CATHETER WHILE IT WAS INSIDE THE SHEATH. THE ATHERECTOMY CATHETER WAS REMOVED (ALL PIECES) AND AN EVERFLEX STENT WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361606 ↗
• InjuryNov 19, 2019Positioning Problem; Physical Resistance/Sticking; Positioning Problem; Physical Resistance/Sticking

  PHYSICIAN USED A TURBOHAWK BTK DEVICE WITH A 6FR SHEATH DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID LEFT ANTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. THE LESION LENGTH WAS 40 MM. IFU WAS FOLLOWED. PRE-DILATION WAS NOT PERFORMED. NO EMBOLIC PROTECTION WAS USED. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED THE DEVICE WAS STICKING WHILE TRYING TO TORQUE AND THEN WOULD SPIN IN THE ARTERY WITHOUT ANY PASSES MADE WITH THE DEVICE. NO TREATMENT WAS GIVEN WITH THIS DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH THE CUTTER BLADE INSIDE THE HOUSING. THE ARTERY WAS STENTED TO COMPLETE THE PROCEDURE, WHICH WAS NOT PART OF THE PLANNED ORIGINAL PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339761 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A TURBOHAWK DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S DISTAL POPLITEAL ARTERY. SLIGHT TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. NO RESISTANCE WAS FELT. IT IS REPORTED THAT TIP DETACHMENT OCCURRED. THE TIP IS NOT REPORTED TO HAVE SEPARATED AT THE HINGE PIN. THE TIP WHERE NOSECONE CAN BE ALIGNED DETACHED RIGHT AT THE END OF SHEATH, SO THEY WERE ABLE TO REMOVE SAFELY. A NEW HAWKONE WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9190117 ↗
• MalfunctionMay 24, 2019Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A TURBOHAWK TO TREAT A SEVERELY CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE PROXIMAL/MID/DISTAL RIGHT POSTERIOR TIBIAL ARTERY. ARTERY DIAMETER 2.5 ¿ 3 MM. MODERATE TORTUOSITY WAS REPORTED. A 6FR COOK SHEATH AND A COOK 300 MM APPROACH 25 CTO GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED. THE IFU WAS FOLLOWED AND THE GUIDEWIRE WAS HYDRATED DURING PREP. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. ATHERECTOMY WAS COMPLETED AND ARTERY WAS POST-DILATED WITH NO ISSUE. IT WAS REPORTED THAT THE BLACK WIRE ON THE BODY OF THE DEVICE SPLIT. THE TIP WAS THE ONLY PIECE WHICH REMAINED ON THE WIRE. THE DEVICE WAS INTACT AND SOME DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. THE GUIDEWIRE WAS NOT TORN FROM THE DISTAL TIP AND THE GUIDEWIRE DID NOT LOCK-UP ON THE CATHETER. THE SPLIT WAS REPRODUCED OUTSIDE OF THE PATIENT. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND IT WAS NOTED THAT THE DEVICE WAS DAMAGED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639686 ↗