TurboHawkTM TH-LS-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684065747), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2017Device Damaged by Another Device; Device Damaged by Another Device

  THE PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY CALCIFIED LESION IN THE SFA. THE ARTERY WAS 5-6 MM IN DIAMETER. THE DEVICE WAS PREPPED AS PER THE IFU. A 7 FRENCH NON-MEDTRONIC SHEATH WAS USED AND WITH A "0.014 NON-MEDTRONIC GUIDEWIRE. IT WAS REPORTED THAT AFTER 4 SUCCESSFUL PASSES WITH THE TURBOHAWK DEVICE, THE PHYSICIAN NOTICED THE DEVICE WAS NOT SHOWING AS FULL BUT FELT AS IF IT WAS. THE DEVICE WAS INSPECTED, WHEN THE DEVICE WAS REMOVED SOMETHING THAT LOOKED LIKE A PIECE OF PLASTIC WAS FOUND IN THE CUTTER WINDOW. THE CUTTER COULD NOT BE RETURNED TO THE HOUSING. A PTA BALLOON AND STENT WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881684 ↗