Turbo-Elite Laser Atherectomy Catheter 410-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132024703), received between May 10, 2019 and Apr 16, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION USING A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING PREPARATION FOR USE, THE CATHETER WAS DAMAGED, AND LASER LIGHT WAS PROJECTING FROM THE AREA. A NEW TURBO-ELITE WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24901858 ↗
• MalfunctionApr 7, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH USE OF A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING USE, THE CATHETER WAS UNABLE TO CROSS THE LESION, AND EXPOSED FIBERS WERE OBSERVED. THE PROCEDURE WAS COMPLETED WITH A NEW TURBO-ELITE, WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24809189 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, ACCESSING THE LESION FROM THE FEMORAL AND BRACHIAL ARTERIES, USING A CONTRALATERAL APPROACH (LESION ON OPPOSITE SIDE OF THE BODY FROM THE ACCESS SITE). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHEN REMOVING THE TURBO-ELITE FROM THE BODY, IT APPEARED STUCK ON THE INTRODUCER SHEATH, WHICH WAS POSITIONED ACROSS THE CURVE IN THE VASCULATURE, NEAR THE FEMORAL SITE. HOWEVER, AFTER A FEW SECONDS OF PULLING, THE DEVICE WAS SUCCESSFULLY REMOVED AND APPEARED INTACT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. BASED UPON THE DEVICE EVALUATION, A BREACH IN THE OUTER JACKET, ALONG WITH EXPOSED FIBERS IN THE AREA, WAS DISCOVERED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18144903 ↗
• MalfunctionMay 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE PROXIMAL COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN USED A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. THE TURBO ELITE WAS INSERTED INTO THE OUTER SHEATH WHERE RESISTANCE WAS FELT BY THE OPERATING PHYSICIAN; IT WAS DIFFICULT TO PULL THE CATHETER BACK OUT. ONCE THE TURBO ELITE WAS REMOVED FROM THE OUTER SHEATH, IT WAS DISCOVERED THAT THE CATHETER WAS SPLIT OPEN AND THE WIRES (FIBERS) INSIDE THE CATHETER WERE EXPOSED. THE TURBO ELITE WAS DISCARDED AND ANOTHER TURBO ELITE WAS USED TO SUCCESSFULLY COMPLETE THE CASE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14318176 ↗
• MalfunctionApr 19, 2021Break; Break

  A PHILIPS REPRESENTATIVE BECAME AWARE THAT ON 23 MAR 2021, A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED. PATIENT AND CASE DETAILS ARE UNAVAILABLE, ALTHOUGH REQUESTED. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS REPORTED THAT DURING USE IN THE PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE SIDE OF THE DEVICE. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A SECOND DEVICE, WITH NO REPORTED PATIENT HARM. FROM THE INFORMATION OBTAINED, THIS REPORT IS BEING SUBMITTED 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 TURBO ELITE DEVICE FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11689802 ↗
• MalfunctionMar 10, 2020Break; Break

  A PERIPHERAL VASCULAR INTERVENTION COMMENCED AND DURING PREPARATION FOR USE, A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS FOUND TO NOT LOAD ON THE GUIDE WIRE. IT WAS REPORTED THAT THE DEVICE NEVER ENTERED THE BODY. THE PHYSICIAN USED ANOTHER DEVICE AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND WAS EVALUATED ON (B)(6) 2020. FROM THE DEVICE EVALUATION FINDINGS, IT WAS DETERMINED THAT THIS IS A REPORTABLE EVENT DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.

  Patient problems: Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 9811213 ↗
• MalfunctionMay 10, 2019Break; Deformation Due to Compressive Stress; Material Integrity Problem; Break; Deformation Due to Compressive Stress; Material Integrity Problem

  A PERIPHERAL PROCEDURE COMMENCED TO TREAT A STENOSED VESSEL IN A MID TO DISTAL SUPERFICIAL FEMORAL ARTERY OF MIXED MORPHOLOGY AND MODERATE CALCIFICATION. THE PHYSICIAN REPORTEDLY SUCCESSFULLY CROSSED THE LESION WITH A WIRE, AND THEN WITH A CROSSING CATHETER. A SPECTRANETICS TURBO ELITE DEVICE WAS THEN USED TO TREAT THE LESION. THE PHYSICIAN REPORTEDLY MET RESISTANCE WHILE LASING; HE WAS ABLE TO CROSS THE LESION, BUT IT WAS TIGHT. THE FLUENCY OF THE DEVICE WAS INCREASED AND ANOTHER PASS WAS ATTEMPTED AT CROSSING THE LESION AGAIN. HOWEVER, THE PHYSICIAN REPORTED THAT PASSING THE LASER "DIDN'T FEEL RIGHT" AND REMOVED THE DEVICE TO OBSERVE IT. THE DEVICE WAS REPORTEDLY MANGLED. THE PHYSICIAN THEN USED ANOTHER TURBO ELITE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO REPORTED PATIENT HARM. WHEN THE TURBO ELITE DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED, IT WAS DISCOVERED THAT THERE WAS A BREACH IN THE DEVICE'S OUTER JACKET. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AND ACCIDENTAL RADIATION.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8602048 ↗