TurboHawkRecalls & reported problems across all models

We found 6 models of TurboHawk by Covidien LP in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Jan 9, 2024 — classified as 13 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TurboHawk problems

TurboHawk models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TurboHawk™ THS-LS-C

  Catheter, peripheral, atherectomy
  13 reports
• TurboHawk™ THS-LX-C

  Catheter, peripheral, atherectomy
  13 reports
• TurboHawk™ THS-SX-C

  Catheter, peripheral, atherectomy
  12 reports
• TurboHawk™ THS-SS-CL

  Catheter, peripheral, atherectomy
  9 reports
• TurboHawk™ TH-LX-M

  Catheter, peripheral, atherectomy
  7 reports
• TurboHawk™ THS-SX-C

  Catheter, peripheral, atherectomy
  2 reports

Recent TurboHawk adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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