TurboHawk™ Plus THP-LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000402372), received between May 21, 2024 and Apr 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY USING THE TURBOHAWK PLUS CUTTING CATHETER, SEVERAL PROCEDURAL ISSUES OCCURRED. THE CATHETER TIP CONNECTION PART WAS BROKEN, THE TIP DETACHED, AND SEVERE RESISTANCE WAS FELT DURING ADVANCEMENT. ADDITIONALLY, THE TIP SEPARATED AT THE HINGE PIN, AND A KINK WAS OBSERVED DURING SECOND ADVANCEMENT AT THE CUT WINDOW. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER PRODUCT. THE PATIENT WAS TREATED FOR A CALCIFIED, CHRONIC TOTAL OCCLUSION (100% STENOSIS) IN THE MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS POST-DILATED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857106 ↗
• InjuryDec 11, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE RIGHT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY WITH 80% STENOSIS AND AN 80MM LESION LENGTH, THERE WERE DEVICE-RELATED ISSUES INVOLVING THE TURBOHAWK PLUS LS AND THE SPIDER FX DEVICES. MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. ARTERY DIAMETER REPORTED AS 7MM. THE PROCEDURE INVOLVED THE USE OF A NON-MEDTRONIC 7F SHEATH, AND PRE- AND POST-DILATION WITH 3MM AND 6MM NANOCROSS DEVICES, RESPECTIVELY. THE PHYSICIAN MADE SEVERAL PASSES WITH TURBOHAWK PLUS. UPON CLEANING AND REINSERTING THE DEVICE INTO THE BODY, THE TURBOHAWK PLUS NOSE BECAME BOUND TO THE SPIDER FX WIRE, MAKING IT EXTREMELY DIFFICULT TO ADVANCE. SEVERE RESISTANCE WAS ENCOUNTERED FOR EACH DEVICE, AND EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. REMOVAL DIFFICULTIES WERE REPORTED. THE PHYSICIAN USED CLAMPS AND A TECHNICIAN'S AID TO FORCEFULLY REMOVE THE HAWK FROM THE SHEATH AND PULL IT OFF THE WIRE. THE DEVICES WERE REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY, AND THE PROCEDURE WAS COMPLETED USING NEW MEDTRONIC DEVICES, SPECIFICALLY A TURBOHAWK PLUS LS AND A 6MM SPIDER FX, WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902962 ↗
• MalfunctionAug 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK PLUS ATHERECTOMY DEVICE WITH A 45CM 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL CALCIFICATION WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A MECHANICAL JAM WAS REPORTED. IT WAS REPORTED THE CUTTER DRIVER/THUMBSWITCH STOPPED FUNCTIONING WHILE DEVICE IN USE IN PATIENT. THE CUTTER WAS OUTSIDE THE HOUSING WHEN DEVICE CRASHED. THE CUTTER WAS OUTSIDE HOUSING DURING REMOVAL FROM THE PATIENT. NO DEFORMATION WAS NOTICED TO THE CUTTER. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT TURBOHAWK PLUS DEVICE USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947180 ↗
• MalfunctionMay 21, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK PLUS ATHERECTOMY DEVICE WITH A 45CM 7FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A 6MM SPIDER EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 WITHOUT ISSUE. EMBOLIC PROTECTION WAS USED. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE TECOTHANE JACKET WAS DAMAGED. THE LINING APPEARED TO SLIP OFF. NO PIECES WERE MISSING. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360037 ↗

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.