TurboHawk™ TH-LX-M (UDI 00763000918934)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000918934), received between Mar 12, 2025 and Sep 17, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805233 ↗
• MalfunctionJul 8, 2026Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE WAS USED DURING A DIRECTIONAL ATHERECTOMY PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (100% STENOSIS) IN THE MID SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY, WITH THE TARGET LESION DESCRIBED AS CALCIFIED PLAQUE/SOFT TISSUE. THE VESSEL WAS PRE-DILATED WITH A 3.5 BALLOON, AND THE DEVICE WAS THEN USED TO START CUTTING FROM THE ORIGIN SITE OF THE LESION. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE CUTTER COULD NOT EFFECTIVELY CUT TISSUE, AND THE CATHETER KINKED WHEN ADVANCED FORWARD, PREVENTING SMOOTH ADVANCEMENT. REPEATED ATTEMPTS TO ADVANCE AND USE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE WAS EXCHANGED FOR ANOTHER DEVICE OF THE SAME TYPE TO COMPLETE THE PROCEDURE. NO POST-DILATION WAS PERFORMED. INSTRUCTIONS FOR USE WERE REPORTED AS FOLLOWED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETUNED FOR EVALUATION, IT WAS NOTED THAT THE DEVICE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750763 ↗
• MalfunctionMay 5, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PERIPHERAL/ENDOVENOUS DIRECTIONAL ATHERECTOMY USING THE TURBOHAWK ATHERECTOMY CATHETER TO TREAT A PROXIMAL SUPERFICIAL FEMORAL ARTERY LESION WITH CALCIFIED, FIBROUS PLAQUE AND 85% STENOSIS, TISSUE WAS UNABLE TO BE FLUSHED. THE EXCISED PLAQUE COULD NOT BE PUSHED OUT, AND WHEN AN ATTEMPT WAS MADE TO RESTART THE DEVICE, THE THUMB SWITCH COULD NOT BE PUSHED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION WAS NOTICED IN THE CUTTER. THE CATHETER WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RECEIVDD FOR EVALUATION, IT WAS NOTED THAT THE HOUSING WALL & TECOTHANE HAD A HOLE IN THE CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25079018 ↗
• MalfunctionFeb 23, 2026Material Deformation

  IT WAS REPORTED THAT DURING A TARGETED RESECTION PROCEDURE USING THE ATHERECTOMY TH-LX-M TURBOHAWK ATK, AFTER A PORTION OF PLAQUE HAD BEEN REMOVED FROM THE MID SUPERFICIAL FEMORAL ARTERY, THE CATHETER WAS WITHDRAWN FOR CLEANING. THE PLAQUE IN THE COLLECTION CHAMBER COULD NOT BE FLUSHED OUT, AND A PROTRUSION WAS OBSERVED IN THE COLLECTION CHAMBER, MAKING IT IMPOSSIBLE TO CONTINUE USING THE DEVICE. AFTER INSPECTION IT WAS CONFIRMED THAT THE TECOTHANE JACKET WAS NOT COMPROMISED. A NEW HAWK CATHETER WAS USED TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE DEVICE WAS DAMAGED AT THE HINGE PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413809 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TARGETED RESECTION PROCEDURE USING THE TURBOHAWK ATK, A PATIENT PRESENTED WITH SEVERE CALCIFICATION AND 80% STENOSIS OF THE MID SUPERFICIAL FEMORAL ARTERY. THE CUTTER HEAD DETACHED AND COULD NOT BE PULLED OUT. NO PROCEDURAL STROKE CINERADIOGRAPHY IMAGES WERE AVAILABLE. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED, AND INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161883 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TARGETED EXCISION SURGERY FOR A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY, WHICH WAS CHARACTERIZED BY SEVERE CALCIFICATION, CALCIFIED PLAQUE, AND 70% STENOSIS, THE BLADE  TURBO HAWK ATK DEVICE COULD NOT BE PUSHED INTO THE COLLECTION CHAMBER AFTER THE FIRST PASS THROUGH THE LESION. THE THUMB SWITCH COULD NOT BE TURNED OFF. DURING THE CUTTING PROCESS, IT WAS FOUND THAT THE BLADE COULD NOT BE RETURNED TO THE COLLECTION BIN. AFTER THAT, THE POWER WAS TURNED OFF AND THE ENTIRE DEVICE WAS SUBSEQUENTLY WITHDRAWN FROM THE BODY, SAFELY REMOVED. THE TOOL IS DEFORMED AND NO PART OF THE TOOL WAS FOUND MISSING. THE COLLECTION BIN AND CONDUIT ARE NOT COMPLETELY DISCONNECTED. BALLOON DILATION WAS THEN PERFORMED ON THE LESION, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE VESSEL WAS BOTH PRE-DILATED AND POST-DILATED. THE PATIENT HAD A HISTORY OF SMOKING. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INFECTIONS, DEATHS, OR ANATOMICAL ABNORMALITIES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS EVALUATED IT WAS NOTED THAT THE TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160703 ↗
• MalfunctionNov 5, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE USING THE TURBOHAWK DEVICE FOR TREATMENT OF A RIGHT MID SUPERFICIAL FEMORAL ARTERY LESION WITH 70% STENOSIS, MODERATE CALCIFICATION, AND FIBROUS AND CALCIFIED PLAQUE, SEVERAL DEVICE ISSUES OCCURRED. PREOPERATIVE PREPARATION WAS PERFORMED ACCORDING TO INSTRUCTIONS, INCLUDING PRE-DILATION WITH A 3.0 MILLIMETER BALLOON. DURING THE FIRST INSERTION, THE CUTTING HEAD WAS ADVANCED THROUGH THE LESION AND THEN WITHDRAWN FOR CUTTING FROM THE PROXIMAL TO DISTAL END. UPON REACHING THE DISTAL END AND ATTEMPTING TO RETRIEVE THE CUTTING HEAD, THE THUMB SWITCH COULD NOT BE PUSHED NORMALLY. THE SURGEON TURNED OFF THE HANDLE SWITCH AND ATTEMPTED MULTIPLE TIMES TO PUSH AND RETRIEVE, BUT THE SWITCH COULD NOT BE CLOSED PROPERLY, RESULTING IN A PROCEDURAL DELAY. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS FOUND THAT THE PROXIMAL COLLECTION CHAMBER OF THE CUTTING HEAD HAD BEEN DAMAGED BY THE CUTTING HEAD ITSELF, THE CUTTER WAS DAMAGED, AND THE FLUSH PORT ON THE CATHETER HANDLE WAS ALSO DAMAGED. THE DAMAGED CUTTER REQUIRED RETRIEVAL FROM THE PATIENT BY REMOVING THE ENTIRE DEVICE. THE SURGEON REPLACED THE DEVICE WITH THE SAME MODEL A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477371 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE USING THE TURBOHAWK ATK, A PATIENT WITH A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE MID SUPERFICIAL FEMORAL ARTERY, SEVERE VESSEL TORTUOSITY, AND MODERATE LESION CALCIFICATION UNDERWENT PUNCTURE ANGIOGRAPHY, WHICH REVEALED FEMORAL ARTERY OCCLUSION AND POOR VISUALIZATION OF THE POPLITEAL ARTERY. AFTER GUIDEWIRE PASSAGE THROUGH THE OCCLUDED SEGMENT, THE ATHERECTOMY CATHETER WAS INSTALLED AND FLUSHED, AND A SMALL BALLOON WAS USED FOR PRE-DILATION. DURING ADVANCEMENT OF THE ATHERECTOMY CATHETER, RESISTANCE WAS FELT AND AN ABNORMAL SOUND WAS NOTED. ANGIOGRAPHY SHOWED AN ABNORMALITY AT THE TIP OF THE CATHETER. UPON WITHDRAWAL AND INSPECTION, DEFORMATION AND CRACKING OF THE TIP AND COLLECTION CHAMBER WERE OBSERVED, AND THE DEVICE COULD NOT BE USED. THE DAMAGED COMPONENT WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE SURGICAL TECHNIQUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084195 ↗
• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE USING THE ATHERECTOMY TH-LX-M TURBOHAWK ATK, A PATIENT PRESENTED WITH A 70% STENOSIS LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY CHARACTERIZED AS CALCIFIED, FIBROUS, AND PLAQUE. MODERATE CALCIFICATION WAS NOTED, AND THE ARTERY DIAMETER WAS 6 MILLIMETERS. NO ISSUES DURING PREPARATION. A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS PRE-DILATED AND POST-DILATED. DURING THE PROCEDURE, A DAMAGED CUTTER COMPONENT WAS DETECTED; HOWEVER, NO RESISTANCE WAS FELT DURING ADVANCEMENT, AND THE DAMAGED COMPONENT DID NOT REQUIRE RETRIEVAL FROM THE PATIENT. AFTER THE DEVICE WAS REMOVED FROM THE BODY, THE CUSTOMER REPEATEDLY INSPECTED THE DAMAGED DEVICE, AND THE PISTON INSIDE THE COLLECTION CHAMBER FELL OUTSIDE (ON THE GROUND). A REPLACEMENT TURBOHAWK LX-M WAS USED TO COMPLETE THE PROCEDURE, AND THE SURGERY PROCEEDED SMOOTHLY WITHOUT IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935948 ↗
• MalfunctionAug 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE USING THE TURBOHAWK DEVICE FOR AN 80% STENOSIS WITH PLAQUE IN THE FEMORAL ARTERY, THE HAWK BLADE COULD NOT BE FULLY RETRACTED. AFTER PLACEMENT OF AN EMBOLIC PROTECTION DEVICE AT THE DISTAL END, ROTARY CUTTING WAS PERFORMED, AT WHICH POINT THE INABILITY TO FULLY RETRACT THE BLADE WAS IDENTIFIED. TO AVOID POTENTIAL VASCULAR DAMAGE, THE DEVICE WAS PROMPTLY WITHDRAWN FROM THE BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WAS NO VESSEL DAMAGE. SUBSEQUENTLY, BALLOON DILATATION DRUG COATED BALLOON TREATMENT WAS PERFORMED, AND THE EMBOLIC PROTECTION DEVICE WAS REMOVED. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR INJURIES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE TIP WAS DETACHED AT THE HINGE PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747228 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATK ATHERECTOMY DEVICE FOR TREATMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (POPLITEAL ARTERY) OF A PATIENT WITH CALCIFICATION, TORTUOSITY AND 80% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT SURGICAL ANGIOGRAPHY REVEALED CALCIFICATION AND SHORT SEGMENT STENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, SO THE SURGEON PREPARED TO USE TURBOHAWK ATK FOR ROTATION EXCISION. NO ABNORMALITIES WERE FOUND WHEN FLUSHING THE DEVICE. IT ENTERED THE BODY, PASSED THROUGH THE LESION, AND RETURNED TO THE PROXIMAL END, TURNED ON THE SWITCH FOR ROTATION EXCISION, BUT FOUND THAT IT COULD NOT BE ADVANCED, SO THE DEVICE WAS WITHDRAWN AND OBSERVED THAT THE BLADE WAS DAMAGED, SO THE SURGEON REPLACED IT WITH TURBOHAWK PLUS FOR ROTATION EXCISION AND PERFORMED THE OPERATION NORMALLY. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880226 ↗
• MalfunctionApr 1, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATK ATHERECTOMY DEVICE FOR TREATMENT IN A PATIENT IN THE MID/DISTAL POPLITEAL ARTERY WITH TORTUOSITY, PLAQUE AND CALCIFICATION WITH 80% STENOSIS. THE DEVICE PREPPED AS PER IFU. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO FLUSH TISSUE. A HARD PLASTIC/HARD MASS WAS FOUND IN THE COLLECTION BIN, AND IT MADE IT IMPOSSIBLE TO CLEAN THE DEVICE. THE PROCEDURE WAS COMPLETED BY BALLOON DILATATION, AND A DRUG-COATED STENT WAS IMPLANTED. NO INJURY TO PATIENT REPORTED. WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE DEVICE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737887 ↗
• InjuryMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE INVOLVING THE ATHERECTOMY TH-LX-M TURBOHAWK ATK DEVICE, A DAMAGED COMPONENT WAS NOTED. THE PROCEDURE WAS PERFORMED ON THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, WHICH HAD A CALCIFIED TARGET LESION WITH A MODERATE DEGREE OF TORTUOSITY AND CALCIFICATION. DURING THE PROCEDURE, THE CUTTER COMPONENT WAS REPORTED AS DAMAGED. THE DAMAGED COMPONENT NEEDED TO BE RETRIEVED FROM THE PATIENT, WHICH WAS ACCOMPLISHED USING A SUCTION DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW MEDTRONIC ROTARY CUTTING DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581632 ↗