TurboHawk™ Plus THP-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00763000402396), received between Mar 14, 2022 and Sep 1, 2026 — classified as 10 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K212027); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, 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 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 ↗
• 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 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE ON THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE TURBOHAWK PLUS-M DEVICE, THE TARGET LESION WAS CHARACTERIZED AS CALCIFIED, FIBROUS, PLAQUE, AND SOFT TISSUE, WITH A CHRONIC TOTAL OCCLUSION AND 100% STENOSIS. DURING THE PROCEDURE, THE TIP OF THE DEVICE DETACHED AND WAS DAMAGED, WITH SEVERE RESISTANCE FELT DURING WITHDRAWAL. THE TIP SEPARATED AT THE HINGE PIN, AND THE PROXIMAL END OF THE COLLECTION CHAMBER DETACHED FROM THE METAL JUNCTION. THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL METHOD TO BALLOON DILATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856465 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A TURBOHAWK ATHERECTOMY DEVICE, ISSUES WERE ENCOUNTERED IN THE LEFT SUPERFICIAL FE MORAL ARTERY AT A DISTAL LOCATION. THE TARGET LESION WAS CALCIFIED WITH SEVERE CALCIFICATION AND MINIMAL TORTUOSITY, EXHIBITING 100% STENOSIS OVER A LENGTH OF 100MM, AND THE ARTERY DIAMETER WAS 5MM. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE TIP WAS DAMAGED WITH THE GUIDEWIRE LUMEN TORN/RIPPED. THE TIP DID NOT DETACH. THE VESSEL WAS PRE-DILATED AND POST-DILATED USING SPECIFIED DILATION DEVICES. DESPITE THE RESISTANCE, NO EXCESSIVE FORCE WAS USED, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE OF THE SAME MODEL. WHEN THE DEVICE WAS RETURNED FOR ANALYSIS, IT WAS NOTED THAT THE DEVICE WAS DETACHED FROM THE HINGE PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419570 ↗
• MalfunctionFeb 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 INVOLVING THE TURBOHAWK PLUS 6F, IT WAS FOUND THAT THERE WAS A BREAKAGE DURING THE FLUSHING STAGE. THE PROCEDURE WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, TARGETING A CALCIFIED, FIBROUS PLAQUE WITH A CHRONIC TOTAL OCCLUSION OF 100%. THE ARTERY DIAMETER RANGED FROM 4MM TO 5MM, AND THE LESION LENGTH WAS 100MM. MODERATE CALCIFICATION AND LITTLE TORTUOSITY WERE NOTED. DURING THE PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT, AND THE CUTTER WAS REPORTED AS DAMAGED. THE EXPOSED BLADE WAS FOUND TO BE BROKEN DURING THE FLUSHING STAGE, AND SERIOUS BREAKAGE WAS OBSERVED WHEN THE BLADE WAS PUSHED. THE PROCEDURE INVOLVED PRE-DILATION AND POST-DILATION OF THE VESSEL, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND NO ABNORMALITIES SUCH AS STICKING WERE FOUND. NO RESIDUE WAS SEEN IN THE EMBOLIC PROTECTION DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT SYMPTOMS OR COMPLICATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401438 ↗
• MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TURBOHAWK PLUS, A DETACHMENT OCCURRED WITH THE NOSECONE OF THE DEVICE DURING CLEANING POST-USE, NOT INSIDE THE PATIENT. THE PROCEDURE WAS CONDUCTED ON THE RIGHT PERIPHERAL ARTERIES, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WHICH HAD CALCIFIED PLAQUE WITH SEVERE CALCIFICATION AND MINIMAL TORTUOSITY. THE LESION STENOSIS WAS BETWEEN 75-95% OVER A LENGTH OF 400MM, WITH AN ARTERY DIAMETER OF 4.0-5.5MM. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373599 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A TURBOHAWK PLUS DEVICE, MINIMAL RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DEVICE OVER THE WIRE INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY AT THE PROXIMAL LOCATION. THE TARGET LESION WAS CALCIFIED WITH A MODERATE DEGREE OF CALCIFICATION, 70% STENOSIS, AND A LENGTH OF 40 MILLIMETERS, WITH AN ARTERY DIAMETER OF 6.5 MILLIMETERS. AFTER THE THUMBSWITCH WAS POSITIONED TO THE ON POSITION, A DEEP PITCH SOUND WAS NOTED. THE PROXIMAL PART OF THE NOSECONE SEPARATED FROM THE CATHETER BUT REMAINED INTACT, AND DEVICE DETACHMENT OCCURRED AT THE TARGET LESION. THE PROXIMAL PART OF THE NOSECONE DID NOT FULLY DETACH FROM THE CATHETER AND THEREFORE THE DEVICE WAS REMOVED AS ONE COMPLETE UNIT. THE PHYSICIAN THEN CONVERTED TO PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO COMPLETE THE PROCEDURE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND NO INJURY OR INTERVENTION WAS 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 21364070 ↗
• MalfunctionJan 13, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK PLUS ATHERECTOMY DEVICE FOR PATIENT TREATMENT IN THE POPLITEAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A NON-MEDTRONIC SHEATH (7F COOK) WAS USED. IFU WAS FOLLOWED. IT IS REPORTED THAT WHEN THE PRODUCT WAS PASSED THROUGH THE GUIDEWIRE OUTSIDE THE PATIENT'S BODY, THERE WAS OBVIOUS RESISTANCE, AND THE GUIDEWIRE COULD NOT PASS THROUGH THE INSIDE OF THE PRODUCT. DURING THE PERCUTANEOUS PUNCTURE ANTEGRADE POPLITEAL ARTERY OPENING SURGERY, THE SURGEON USED THE DISPOSABLE PERIPHERAL PLAQUE REMOVAL DEVICE, THE PRODUCT NEEDED TO PASS THROUGH THE GUIDE WIRE TO REACH THE LESION SITE, HOWEVER, IN THE PROCESS OF PASSING THE GUIDE WIRE THROUGH THE PRODUCT, ENCOUNTERED OBVIOUS RESISTANCE, RESULTING IN THE GUIDE WIRE UNABLE TO PASS THROUGH IN THE PRODUCT. THEN, THE SURGEON REPLACED IT WITH ANOTHER SURGICAL DEVICE, USING ORDINARY BALLOONS AND DRUG-COATED BALLOONS FOR COMBINED TREATMENT TO COMPLETE THE OPERATION. THERE WAS A BREAK BETWEEN THE BLADE AND THE WIRE THAT DROVE THE BLADE. THE SURGERY WAS CONTINUED BY REPLACING WITH ANOTHER DEVICE AND WITH THE COOPERATION OF SPIDER FX TO COMPLETE THE SURGERY SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136682 ↗
• InjuryJan 8, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ATHERECTOMY TH PLUS 6F DEVICE, THE NOSE CONE DETACHED WITHIN THE SHEATH IN THE PATIENT. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. THE PROCEDURE WAS ASSOCIATED WITH THE PERIPHERAL ARTERIES, SPECIFICALLY THE LEFT MID COMMON ILIAC ARTERY AND POPLITEAL ARTERY, WHERE A CALCIFIED TARGET LESION WITH 70% STENOSIS AND A LENGTH OF 30 MILLIMETERS WAS PRESENT. THE ARTERY DIAMETER WAS NOTED TO BE 6 MILLIMETERS. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS ABORTED, AND THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103209 ↗
• MalfunctionDec 2, 2024Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  A TURBOHAWK PLUS WAS BEING USED FOR TREATMENT OF A 150MM CALCIFIED/PLAQUE LESION WITH 100% STENOSIS IN THE MID RIGHT POPLITEAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH SEVERE CALCIFICATION. A 7FR NON MEDTRONIC SHEATH WAS USED WITH A 7MM SPIDER GUIDEWIRE. SPIDER FX WAS USED FOR EMBOLIC PROTECTION. AN EVERCROSS WAS USED FOR PREDILATION AND A NANOCROSS WAS USED FOR POST DILATION. THE TURBOHAWK DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS MET DURING ADVANCEMENT. THE IFU WAS FOLLOWED WITHOUT ISSUE. IT WAS REPORTED THE DEVICE WAS USED IN THE PATIENT TWICE AND THEN REMOVED FOR CLEANING. THE COATING OF THE DEVICE SEPARATED FROM THE WIRE WHEN PULLING THE CLEANING TOOL TO THE TOP. ANOTHER TURBOHAWK WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820190 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE DID NOT ENTER THE PATIENTS BODY, THE SPIDER WAS WAS POSITIONED IN THE POPLITEAL SPACE. AS THEY LOADED THE DEVICE ON THE SPIDER WIRE, SIGNIFICANT RESISTANCE WAS MET ABOUT HALFWAY DOWN THE WIRE TO THE POINT THEY WERE UNABLE TO ADVANCE ANY FURTHER. THEY REMOVED THE DEVICE, WITH DIFFICULTY, AND LOADED A DIFFERENT THP-M ON THE SAME WIRE AND FINISHED THE CASE SUCCESSFULLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650803 ↗
• MalfunctionNov 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A TURBOHAWK PLUS AND TWO EVERCROSS BALLOONS TO TREAT A PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. VESSEL WAS NOT PRE-DILATED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IFU WAS FOLLOWED WITHOUT ISSUE. THE FIRST EVERCROSS BALLOON WAS USED. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IFU WAS FOLLOWED WITHOUT ISSUE. THERE WAS TRACKING DIFFICULTY DURING INITIAL ADVANCEMENT AND THE BALLOON GOT STUCK ON A WIRE. A SECOND EVERCROSS BALLOON WAS USED. SEVERE RESISTANCE WAS ALSO ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IFU WAS FOLLOWED WITHOUT ISSUE. IT IS REPORTED THE SECOND BALLOON ALSO GOT STUCK ON WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER EVERCROSS 4X150X135. IT IS REPORTED THAT DURING THE PROCEDURE TECOTHANE JACKET TEAR/CUT/PUNCTURE OF THE TURBOHAWK PLUS OCCURRED. THE DEVICE WAS SAFELY REMOVED FROM PATIENT AND A NEW TURBOHAWK PLUS WAS USED. NO INTERVENTION REQUIRED FOR EITHER OF THE 3 DEVICES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598634 ↗
• MalfunctionOct 24, 2024Material Deformation; Material Deformation

  A PHYSICIAN USED A TURBOHAWK PLUS ATHERECTOMY DEVICE TO TREAT A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY OF A PATIENT. MINIMAL TORTUOSITY, MINIMAL CALCIFICATION AND 90% LESION STENOSIS WERE REPORTED. THE LESION LENGTH WAS 250MM AND ARTERY DIAMETER WAS 5MM. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. A 6FR 45CM TERUMO DESTINATION SHEATH AND SPIDER FX GUIDEWIRE WERE USED. A SPIDER FX WAS USED FOR EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE, WITHOUT ISSUES. IT IS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE TURBOHAWK DEVICE WAS DAMAGED. THE GUIDEWIRE LUMEN WAS NOT TORN OR RIPPED. THE TIP DID NOT DETACH. NO INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH PTA. THE VESSEL WAS POST-DILATED WITH NANOCROSS BALLOON. NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522329 ↗
• MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A TURBOHAWK PLUS WAS BEING USED FOR TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY. A SPIDER FX WAS USED FOR EMBOLIC PROTECTION. THE VESSEL WAS PRE AND POST-DILATED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE IFU WAS FOLLOWED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. IT WAS REPORTED DURING CLEANING POS USE, THE TIP DETACHED. THE GUIDEWIRE LUMEN WAS NOT TORN/RIPPED. THE GUIDEWIRE DID NOT PROLAPSE LEADING TO TIP DETACHMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408254 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE TO A TURBOHAWK PLUS TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS 100%. A TERUMO 6F SLENDER SHORT SHEATH WAS USED. A CORDIS STABILIZER WIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A AB14W05150150. THE VESSEL WAS POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IFU WAS FOLLOWED WITHOUT ISSUE. TIP DETACHED DURING PROCEDURE (IN VIVO) AT THE NOSECONE. THE GUIDEWIRE LUMEN WAS TORN/RIPPED. DETACHED TIP WAS SAFELY REMOVED WITHIN SHEATH. PROCEDURE COMPLETED WITH LASER ATHERECTOMY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212027. One submission often covers many models, so check the product and lot details in each record.

• Z-0695-2022 · Feb 4, 2022 · Terminated
  Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.