TurboHawk™ THS-SX-C (UDI 00821684065853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684065853), received between Apr 5, 2018 and Feb 6, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• MalfunctionFeb 6, 2019Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND 0.014 SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 200MM PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 4MM. NO TORTUOSITY OR CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT THE THUMBWHEEL BECAME JAMMED WHEN TRYING TO TURN OFF THE CUTTER AND PACK THE PLAQUE IN THE NOSECONE. IT WOULD NOT GO ALL THE WAY FORWARD AND STAYED ON. A NEW TURBOHAWK DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310004 ↗
• InjuryApr 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT HAS A HISTORY OF PAD, RENAL FAILURE. THE PHYSICIAN INTENDED TO USE THE TURBOHAWK AND SPIDER FX 5 MM AND 6¿FR BIOTRONIK SHEATH TO TREAT A SEVERELY CALCIFIED LESION, WITH 95-99% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY AS PER IFU. IT WAS REPORTED THAT SEVERE CALCIFICATION NOTED THROUGHOUT THE ILIAC, FEMORAL AND TIBIAL VESSELS. THE TARGET LESIONS WERE CROSSED AND PREDILATED. THE SPIDER WAS PLACED IN THE DISTAL POPLITEAL ARTERY. AFTER PRE-DILATION THE TURBOHAWK WAS DIFFICULT TO PASS THROUGH AND ROTATE, MULTIPLE PASSES WERE COMPLETED. SEVERE RESISTANCE WAS ENCOUNTERED REMOVING THE TURBOHAWK, AFTER FLUOROSCOPIC INSPECTION IT WAS OBSERVED THAT THE WIRE WAS WRAPPED AROUND THE TURBOHAWK. NUMEROUS KINKS WERE OBSERVED IN THE WIRE, ATTEMPTS WERE MADE TO UNTANGLE THE WIRE FROM THE TURBOHAWK. THE DEVICE AND SHEATH WERE PULLED BACK WITH RESISTANCE ACROSS AORTIC BIFURCATION, AS A RESULT THE TURBOHAWK NOSECONE SEPARATED AT THE HINGE POINT FROM THE CATHETER SHAFT IN THE COMMON ILIAC ARTERY. THE SPIDER WIRE DID NOT FRACTURE, THE BASKET WAS IN THE PROXIMAL RIGHT SFA. LEFT SHEATH ACCESS WAS MAINTAINED THE PATIENT WAS TRANSFERRED TO HOSPITAL FOR A RIGHT FEMORAL CUTDOWN TO RETRIEVE THE

  Patient problems: Embolism; Patient Problem/Medical Problem

  MAUDE report 7398771 ↗