Turbo-Elite Laser Atherectomy Catheter 417-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132024741), received between Dec 12, 2019 and May 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMay 15, 2026Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATE PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHILE LASING THROUGH THE LESION, RED LASER LIGHT WAS EMITTING FROM THE TAIL TUBE OF THE DEVICE AND APPEARED TO BE SEPARATING. THE TURBO-ELITE WAS REMOVED AND A BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25185523 ↗
• MalfunctionSep 27, 2021Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION, LOCATION UNK. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING PREPARATION FOR USE, A HOLE IN THE LASER SHEATH WAS OBSERVED. THE DEVICE WAS NOT RETURNED; HOWEVER, PHOTOS OF THE DEVICE SHOWED AN AREA OF THE DEVICE'S TAIL TUBE THAT APPEARED KINKED AND SLIGHTLY TWISTED. A RED DOT WAS PRESENT IN THE PHOTO IN THE AREA OF THE KINK, WHICH COULD INDICATE LASER LIGHT EMITTING FROM THE AREA; HOWEVER THIS COULD NOT BE CONFIRMED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. BASED ON THE PHOTOS PROVIDED, THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12537440 ↗
• MalfunctionOct 16, 2020Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A HEAVILY CALCIFIED LESION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE OF THE DEVICE, IT WAS REPORTED THE DEVICE SEPARATED AT THE TIP WHILE BEING USED WITHIN THE PATIENT. THE PORTION OF THE CATHETER WAS REPORTEDLY RETRIEVED FROM THE PATIENT WITH NO REPORTED PATIENT HARM. ON 15 OCT 2020 THE DEVICE WAS EVALUATED AND IT WAS CONFIRMED THERE WERE NO PORTIONS OF THE DEVICE MISSING. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10692250 ↗
• MalfunctionDec 12, 2019Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL AND POSTERIOR TIBIAL (PT) ARTERIES. DURING USE OF A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER (WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT''S BODY), IT WAS REPORTED THAT THE CATHETER HAD BEEN BROKEN IN HALF; HOWEVER THERE WAS NO REPORTED EMBOLUS, SO NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH USE OF AN IVUS CATHETER AND A SECOND DEVICE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE FOR EVALUATION BUT THE DEVICE HAS NOT ARRIVED AT THIS TIME.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9460275 ↗