TurboHawk PlusRecalls & reported problems across all models

We found 4 models of TurboHawk Plus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2022 and Sep 1, 2026 — classified as 13 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 reports).

2 FDA recall records name at least one of these models by its device identifier.

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

TurboHawk Plus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 4, 2022Terminated

   The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

   Z-0695-2022 · Root cause: Labeling design · Recall details · FDA record ↗

2. Feb 4, 2022Terminated

   The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

   Z-0694-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported TurboHawk Plus problems

TurboHawk Plus models

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

• TurboHawk™ Plus THP-M

  Catheter, peripheral, atherectomy
  1 recall65 reports
• TurboHawk™ Plus THP-S

  Catheter, peripheral, atherectomy
  1 recall6 reports
• TurboHawk™ Plus THP-LX

  Catheter, peripheral, atherectomy
  7 reports
• TurboHawk™ Plus THP-LS

  Catheter, peripheral, atherectomy
  4 reports

Recent TurboHawk Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Difficult to Remove; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542583 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50448999 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT AN ATHERECTOMY TH PLUS 6F WAS USED DURING A PROCEDURE TO TREAT A PLAQUE LESION IN THE MID/DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY WITH SEVERE TORTUOSITY, MODERATE CALCIFICATION, AND A TORTUOUS BIFURCATION. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A 6FR SHEATH AND A 014 NON MEDTRONIC GUIDEWIRE WERE USED. DURING THE PROCEDURE, THE TIP DETACHED AT THE HINGE PIN, AND GUIDEWIRE PROLAPSE WAS REPORTED TO HAVE OCCURRED LEADING TO THE TIP DETACHMENT. THE DETACHED TIP WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A 15-MINUTE DELAY IN SURGERY WAS REPORTED, AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055592 ↗
• MalfunctionApr 17, 2026Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CLEANING PROCESS WITH THE ATHERECTOMY TURBOHAWK PLUS, THE DISTAL FLUSH TOOL BECAME STUCK ON THE DISTAL TIP AND COULD NOT BE ADVANCED BACK TO THE PROXIMAL POSITION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE DEVICE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911702 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (80% STENOSIS, 100 MM LESION LENGTH, 4 MM ARTERY DIAMETER) IN A PATIENT, THE ATHERECTOMY TH PLUS 6F DEVICE EXPERIENCED A MECHANICAL JAM AND THE CUTTER DRIVER/THUMBSWITCH STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. THE CUTTER WAS POSITIONED INSIDE THE HOUSING AND NO DEFORMATION WAS NOTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW ATHERECTOMY TH PLUS 6F DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION IT WAS NOTED THAT THE DEVICE WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838888 ↗
• MalfunctionMar 23, 2026Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE USING THE TURBOHAWK PLUS 6F DEVICE IN THE PROXIMAL SEGMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY, REMOVAL DIFFICULTIES WERE ENCOUNTERED, REQUIRING THE DEVICE TO BE PULLED WITH RESISTANCE. THE GUIDEWIRE LUMEN WAS TORN OR RIPPED, AND TIP DAMAGE WAS OBSERVED, ALTHOUGH THE TIP DID NOT DETACH. MODERATE RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. THE VESSEL EXHIBITED MODERATE TORTUOSITY, MINIMAL CALCIFICATION, AND A CHRONIC TOTAL OCCLUSION WITH A LESION LENGTH OF 250 MILLIMETERS AND AN ARTERY DIAMETER OF 5-6 MILLIMETERS. THE SHEATH USED WAS A 6F TERUMO DESTINATION 45CM, AND THE GUIDEWIRE WAS AN ASAHI .014 GLADIUS. THE VESSEL WAS POST-DILATED WITH A 5X200 IN.PACT ADMIRAL DEVICE. NO VESSEL DAMAGE, INJURY, OR INTERVENTION OCCURRED, AND THE DEVICE WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ATHERECTOMY TH PLUS 6F DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659981 ↗
• MalfunctionMar 20, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT DIRECTIONAL ATHERECTOMY FOR CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE LEFT SUPERFICIAL FEMORAL ARTERY (MID AND DISTAL SEGMENTS), CHARACTERIZED BY 78MM MODERATE CALCIFICATION AND A FIBROUS LESION. THE ARTERY WAS 4.1-4.7MM IN DIAMETER. DURING THE PROCEDURE, THE ATHERECTOMY TH PLUS 6F DEVICE WAS USED FOLLOWING PRE-DILATION WITH A SMALL BALLOON (3.0 MM DIAMETER, 150 MM LENGTH). A 6FR NON MEDTRONIC SHEATH AND A 0.014 GUIDEWIRE WERE USED. A SPIDER WAS USED FOR EMBOLIC PROTECTION. AFTER THE FIRST CUT, THE CUTTER COULD NOT BE PROPERLY RETRACTED INTO THE COLLECTION CHAMBER, AND THE THUMB SWITCH COULD NOT BE RETURNED TO ITS NORMAL POSITION. THE CUTTER REMAINED UNRETRACTABLE REGARDLESS OF THE POWER STATUS (ON OR OFF), AND THE COLLECTION CHAMBER WAS NOT FULLY FILLED AFTER THE FIRST CUT. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE, INCLUDING PRE-PROCEDURE FLUSHING PREPARATION, AND NO ABNORMALITIES WERE NOTED DURING FLUSHING. UPON ENCOUNTERING THE ISSUE, THE DEVICE WAS REMOVED AS A WHOLE AND FLUSHED, BUT THE CUTTER STILL COULD NOT BE RETRACTED. THE DEVICE WAS REPLACED WITH A NEW TURBOHAWK, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648239 ↗
• MalfunctionMar 13, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES (MID AND DISTAL SEGMENTS, 60-80% STENOSIS, 150MM LENGTH, 4-6MM DIAMETER, MODERATE CALCIFICATION, MINIMAL TORTUOSITY) WITH THE ATHERECTOMY TH PLUS 6F DEVICE, A MECHANICAL JAM OCCURRED. A 6FR NON-MEDTRONIC (TERUMO) SHEATH AND A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE WERE USED. NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE VESSEL WAS POST-DILATED WITH AN IPU05015013P INPACT ADMIRAL DCB BALLOON. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. IT WAS REPORTED THAT THE THUMBSWITCH COULD NOT BE TURNED OFF. NO DEFORMATION WAS NOTICED IN THE CUTTER. THE CUTTER WAS POSITIONED OUTSIDE THE HOUSING DURING DEVICE REMOVAL FROM THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW TURBOHAWK PLUS ATHERECTOMY DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589009 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TARGETED EXCISION PROCEDURE USING THE ATHERECTOMY TH PLUS 6F AND ATHERECTOMY FG02550 CUTTERDRIVER DEVICES, THE DEVICE TIP DETACHED AND SEPARATED AT THE HINGE PIN. THE DEVICE WAS FOUND TO BE BROKEN AFTER REMOVAL DURING SURGERY. THE PROCEDURE INVOLVED TREATMENT OF PLAQUE IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY AND PERONEAL ARTERY, WITH MODERATE CALCIFICATION AND LITTLE TORTUOSITY. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED, AND INSTRUCTIONS FOR USE WERE FOLLOWED THROUGHOUT THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504580 ↗
• MalfunctionFeb 6, 2026Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE PROXIMAL SEGMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE ATHERECTOMY TH PLUS 6F DEVICE, MODERATE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. AFTER SUCCESSFUL USE IN THE PROXIMAL SEGMENT, THE DEVICE WAS REMOVED, CLEANED, AND REINSERTED TO TREAT THE DISTAL SEGMENT. ON THE SECOND INSERTION, DIFFICULTY WAS EXPERIENCED TRACKING THE DEVICE OVER THE AORTIC BIFURCATION, AND THE DEVICE BECAME STUCK AT THE BIFURCATION WITHIN THE SHEATH. THE PHYSICIAN PULLED ON THE CATHETER, RESULTING IN DETACHMENT OF THE NOSECONE TIP WITHIN THE SHEATH. THE NON-MEDTRONIC SHEATH WAS NOTED TO BE MANGLED NEAR THE TIP. THE ENTIRE SHEATH WAS REMOVED OVER THE SPIDER WIRE, A NEW SHEATH WAS INSERTED, AND THE SPIDER WAS REMOVED USING A CROSSING CATHETER. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING A NON-MEDTRONIC BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278344 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ATHERECTOMY TH PLUS 6F, REMOVAL DIFFICULTIES WERE ENCOUNTERED AS THE DEVICE REQUIRED PULLING WITH RESISTANCE. THE GUIDEWIRE LUMEN WAS FOUND TO BE TORN/RIPPED. WIRE PROLAPSE OCCURRED. THE DEVICE WAS USED IN THE PERIPHERAL ARTERIES, SPECIFICALLY THE COMMON ILIAC ARTERY AND THE SUPERFICIAL FEMORAL ARTERY, WITH PLAQUE AND SOFT TISSUE IDENTIFIED AS THE TARGET LESIONS. IMAGES WERE AVAILABLE FOR REVIEW. THE DEVICE WAS REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE OR TIP DETACHMENT. EMBOLIC PROTECTION WAS NOT USED, AND THE VESSEL WAS NOT PRE-DILATED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606068 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE PROXIMAL AND MID SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY IN A PATIENT, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TURBOHAWK DEVICE. TIP DAMAGE AND DETACHMENT OCCURRED IN VIVO DURING THE PROCEDURE, SPECIFICALLY AT THE HINGE PIN. THE DETACHED TIP WAS REMOVED WITHIN THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543173 ↗
• MalfunctionSep 10, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF A FIBROUS PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY USING THE ATHERECTOMY TH PLUS 7F EXT TIP, THERE WAS A DELAY IN SURGERY OF FIVE MINUTES DUE TO THE PRODUCT NOT PROPERLY ENGAGING THE OPPOSITE SIDE OF THE VESSEL AND THE JOG NOT WORKING PROPERLY. THE ARTERY DIAMETER WAS 6MM. A 7FR NON-MEDTRONIC SHEATH AND A SPIDER FILTER WIRE FOR EMBOLIC PROTECTION WERE USED. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED. THE DEVICE WAS SAFELY REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW HAWKONE LX ATHERECTOMY DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION IT WAS NOTED THAT THE CUTTER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013766 ↗
• MalfunctionMay 21, 2025Detachment of Device or Device Component; Difficult to Advance; Noise, Audible; Detachment of Device or Device Component; Difficult to Advance; Noise, Audible

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE INVOLVING THE ATHERECTOMY TH PLUS 6F DEVICE, THE PATIENT HAD LESIONS IN THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY CHARACTERIZED BY CALCIFIED PLAQUE WITH MODERATE CALCIFICATION, LITTLE TORTUOSITY AND 90% STENOSIS. DURING THE PROCEDURE, A DAMAGED CUTTER WAS NOTED, AND RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE DEVICE. IT WAS FOUND THAT THE SOUND OF THE BLADE WAS NOT RIGHT. ADDITIONALLY, AFTER THE FIRST PLAQUE REMOVAL, THE EXTERNAL FLUSHING DEVICE WAS TAKEN OUT AND THERE WAS DIFFICULTY IN WITHDRAWING THE GUIDEWIRE, AND THE COLLECTION CHAMBER BROKE DURING FLUSHING, NOT WHILE IN THE BODY. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION AFTER STOPPING PLAQUE ROTATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062140 ↗
• InjuryMay 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TURBOHAWK PLUS ATHERECTOMY DEVICE, THE DEVICE COULD NOT BE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE INVOLVED THE COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY, WITH THE LOCATION WITHIN THE ARTERY BEING PROXIMAL. NO EMBOLIC PROTECTION WAS USED. THE PATIENT WAS TRANSFERRED FROM THE OFFICE-BASED LAB FACILITY TO A HOSPITAL AND ADMITTED FOR SURGERY. A SEPARATE VASCULAR SURGEON PERFORMED A CUT-DOWN TO SUCCESSFULLY REMOVE THE DEVICE. THE DEVICE WAS SAFELY REMOVED AS A RESULT OF THE SURGERY, AND THE PATIENT IS IN RECOVERY. THE PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002684 ↗

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