TurboHawk™ Plus THP-LXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000402358), received between Feb 28, 2022 and Apr 17, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK PLUS ATHERECTOMY DEVICE FOR PATIENT TREATMENT IN THE LEFT PROX/MID SUPERFICIAL FEMORAL ARTERY WITH CALCIFICATION (CTO). NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A NON-MEDTRONIC SHEATH (7F COOK) WAS USED. IFU WAS FOLLOWED. VESSEL WAS PREDILATED. IT IS REPORTED THAT TIP DETACHED / TIP DAMAGE OCCURRED. 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 21111333 ↗
• MalfunctionMay 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  PHYSICIAN INTENDED TO USE A TURBOHAWK PLUS LX ATHERECTOMY DEVICE DURING PATIENT TREATMENT. IT IS REPORTED THAT THE STERILE PACKAGING WAS NOT INTACT, THE GLUE WAS NOT INTACT AT CORNER OF INSIDE PACKAGING. THE ISSUE WAS NOTED PRIOR TO USE. THERE WAS NO DAMAGE NOTED TO OUTER PACKAGING. NO LABELLING ISSUES. NO DAMAGE NOTED TO THE DEVICE. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325741 ↗
• MalfunctionApr 5, 2024Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS 7F DIRECTIONAL ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITH NO ISSUES NOTED. THE VESSEL WAS PRE-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A BULGE IN THE NOSECONE WAS REPORTED. THE TECOTHANE JACKET WAS INTACT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED. IMAGE REVIEW POTENTIALLY SHOWS THAT THE TECOTHANE JACKET MAY HAVE BEEN COMPROMISED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048911 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE TURBOHAWK PLUS ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WAS NO ISSUES IDENTIFIED. IT WAS REPORTED THAT VESSEL DAMAGE/INJURY OCCURRED. IT WAS REPORTED THAT DISSECTION/PERFORATION OCCURRED. NO ISSUE WITH TURBOHAWK DEVICE DURING USE. UNKNOWN IF DEVICE CONTRIBUTED TO THE VESSEL DISSECTION/PERFORATION/INJURY. NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT/WITHDRAWAL OF THE DEVICE. DEVICE WAS SAFELY REMOVED FROM PATIENT. A COVERED STENT WAS USED TO FIX THE ISSUE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 13618746 ↗

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-0694-2022 · Feb 4, 2022 · Terminated
  Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
• 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.