TurboHawk™ Plus THP-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000402419), received between Mar 14, 2023 and Feb 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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-0695-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TURBO HAWK PLUS 6F ATHERECTOMY DEVICE THERE WAS A DELAY OF ONE HOUR DUE TO PRODUCT MALFUNCTION. THE PROCEDURE WAS CONDUCTED ON THE LEFT DISTAL POPLITEAL ARTERY AND TIBIAL/POPLITEAL TRUNK, TARGETING A MODERATELY CALCIFIED LESION. THE PRODUCT ISSUES INCLUDED REMOVAL DIFFICULTIES AND TIP DAMAGE, WITH THE GUIDEWIRE LUMEN BEING TORN OR RIPPED. THE DEVICE WAS SUCCESSFULLY REMOVED WITH RESISTANCE, AND THERE WAS NO VESSEL DAMAGE OR INJURY/INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE AND SHEATH, MAINTAINING WIRE ACCESS, AND SWITCHING TO A LARGER SHEATH AND DIFFERENT WIRES. THE LESION WAS ACCESSED AGAIN, POST-DILATED WITH A NANOCROSS BALLOON, AND A STENT WAS PLACED AND POST-DILATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402519 ↗
• InjuryNov 12, 2024Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  A PHYSICIAN ATTEMPTED TO USE A TURBOHAWK PLUS S ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS RIGHT MID COMMON ILIAC ARTERY. MODERATE VESSEL TORTUOSITY WAS REPORTED. ARTERY DIAMETER REPORTED AS 8MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THEREWAS 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 NOT USED. THE VESSEL WAS PRE-DILATED WITH A 3X150 NANOCROSS BALLOON. THE VESSEL WAS POST-DILATED WITH A 6X200 NANOCROSS BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. TIP DETACHMENT DURING THE PROCEDURE WAS REPORTED. THE GUIDEWIRE LUMEN WAS NOT TORN/RIPPED. THE NON-MEDTRONIC SHEATH AND GUIDEWIRE PROLAPSED INTO AORTA WHEN TRYING TO REMOVE DEVICE AND TURBOHAWK DEVICE GOT STUCK. PHYSICIAN TUGGED AND TURBOHAWK NOSECONE BROKE LEADING TO TIP DETACHMENT. A SNARE WAS USED TO REMOVE DETACHED COMPONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664288 ↗
• MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS S DIRECTIONAL ATHERECTOMY ALONG WITH A 6FR NON-MEDTRONIC SHEATH AND A 300CM 0.014 N ON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS PLAQUE LESION IN THE PATIENTS LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 7MM. LESION EXHIBITED 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTE ACTION 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 WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS POST-DILATED WITH AN EVERCROSS PTA BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE NOSECONE SEPARATED FROM DRIVE SHAFT IN THE PATIENTS VESSEL. THE DETACHED COMPONENT WAS REMOVED WITHIN THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948727 ↗
• MalfunctionJan 18, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS-S 6F ATHERECTOMY DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 85% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS REMOVED FROM THE PATIENT AFTER DOING THE ATHERECTOMY. THE PHYSICIAN WANTED TO CLEAN THE DEVICE. UPON CLEANING THE DEVICE PER IFU THE DEVICE WAS RE-INTRODUCED INTO THE TARGET LESION FOR A SECOND PASS ATHERECTOMY. UPON DELIVERING THE DEVICE BACK INTO THE PATIENT AND TO THE TARGET LESION, THE OPERATOR NOTICED RESISTANCE IN THE THUMB SWITCH AND REMOVED THE DEVICE FOR INSPECTION. UPON INSPECTION, THE PHYSICIAN NOTICED THE NOSE CONE WAS PERFORATED AND DECIDED TO END THE ATHERECTOMY PORTION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535693 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  A PHYSICIAN WAS USING A TURBOHAWK PLUS ATHERECTOMY DEVICE FOR THE TREATMENT OF A 150MM PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL/MID REGION OF THE POPLITEAL ARTERY, TIBIAL/POPLITEAL TRUNK AND POSTERIOR TIBIAL ARTERY. THE ARTERY DIAMETER WAS 3.0-5.5 MM WITH MODERATE TORTUOSITY AND CALCIFICATION. IT WAS REPORTED THE PT OCCLUSION WAS WIRED AND SPIDER EMBOLIC PROTECTION WAS PLACED TO DISTAL POSTERIOR TIBIAL ARTERY (PT) . THE DEVICE WAS PREPPED PER IFU AND NO PROBLEMS WERE IDENTIFIED. PHYSICIAN SUCCESSFULLY DOTTERED THE PT CTO WITH HAWK WITH NO RESISTANCE. SEVERAL PASSES WERE MADE UNTIL THE HAWK WAS FULL. TURBOHAWK PLUS WAS CLEANED PER IFU AND ONCE FINISHED THE DISTAL FLUSHING TOOL WAS ADVANCED TO THE PROXIMAL PART OF THE CATHETER THE RUBBER STRAIN. ONCE THE TECH ADVANCED THE NOSE CONE ONTO THE WIRE IT WAS NOTICED THAT THE DISTAL FLUSHING TOOL ADVANCED TOO FAR ONTO THE RUBBER STRAIN AND WAS K INKING THE CATHETER. ON A STERILE FIELD, OUTSIDE THE PATIENT (DURING CLEANING) THE TURBOHAWK PLUS WAS INSPECTED OFF THE WIRE AND IT WAS IDENTIFIED THAT ADVANCING THE DISTAL FLUSH TOOL ONTO THE RUBBER STRAIN MADE THE CATHETER SEPARATE, THE COMPONENT OF THE CATHETER DID NOT FUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858752 ↗
• MalfunctionMar 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS ATHERECTOMY DEVICE FOR THE TREATMENT OF A 150MM PLAQUE/SOFT TISSUE LESION IN THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY AND TIBIAL/POPLITEAL TRUNK. THE PERCENTAGE OF STENOSIS WAS 80%, THE ARTERY DIAMETER WAS 5MM WITH MODERATE TORTUOSITY AND CALCIFICATION. THE PATIENT HAD MULTIPLE 80% STENOTIC LESIONS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTES AND PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE PROCEDURE AFTER PREPPING THE DEVICE, THE DEVICE WAS USED WITH A 0.014 /300 NITREX AND A 6F NON-MEDTRONIC SHEATH. AFTER A FEW PASSES THE THUMB SWITCH BECAME STUCK/ WOULD NOTCLOSE. THE THUMBSWITCH WAS ABLE TO BE TURNED OFF IN THE MID POSITION WHILE TREATING THE PATIENT. THE POSITION OF THE CUTTER DURING REMOVAL IS UNKNOWN. THE DEVICE WAS SAFELY REMOVED WITHOUT ANY EVENTS. ANOTHER TURBOHAWK WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535923 ↗

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.