Turbo-Elite Laser Atherectomy Catheter 420-159Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00813132024765), received between Aug 28, 2018 and Mar 26, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 15, 2023Class IIOpen, Classified

   Incorrect product labeling. Exterior product box label does not match internal pouch label.

   Z-0509-2024 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION USING A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING CALIBRATION, THE CATHETER WAS NOT RECOGNIZED BY THE PHILIPS LASER SYSTEM. TROUBLESHOOTING WAS PERFORMED, INCLUDING UNPLUGGING AND RE-PLUGGING THE CATHETER INTO THE LASER SYSTEM; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE TURBO-ELITE, WITH NO REPORTED PATIENT HARM. DURING EVALUATION ON (B)(6) 2026, VISUAL INSPECTION FOUND A BREACH WITH BROKEN FIBERS JUST PROXIMAL TO THE MARKER BAND AT THE DISTAL TIP. CALIBRATION WAS NOT POSSIBLE DUE TO THE BREACH AND BROKEN FIBERS. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24706442 ↗
• MalfunctionNov 4, 2025Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). DURING USE OF A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, EXPOSED FIBERS WERE OBSERVED. THE TURBO-ELITE WAS REMOVED AND ANGIOPLASTY WAS PERFORMED 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 23472915 ↗
• MalfunctionJul 5, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE CATHETER'S SHEATH SPLIT APART AND LASER FIBERS WERE VISIBLE. A NEW CATHETER 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 19680687 ↗
• MalfunctionNov 30, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE IN THE PATIENT, THE CATHETER''S DISTAL TIP WAS NOTED TO BE FRAYED AND FLATTENED. USE OF THE TURBO-ELITE WAS DISCONTINUED AND ANOTHER CATHETER WAS USED TO SUCCESSFULLY 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 18242842 ↗
• MalfunctionMar 8, 2023Sharp Edges; Sharp Edges

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED LESION IN THE PATIENT''S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS 2.0 TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT, SUCCESSFULLY COMPLETING ONE PASS THROUGH THE LESION, AND THEN REMOVED FROM THE PATIENT. AS THE DEVICE WAS BEING PREPARED FOR RE-INSERTION INTO THE VESSEL, THE TURBO ELITE FAULTED AND DAMAGE WAS OBSERVED AT THE DISTAL TIP. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. DURING DEVICE EVALUATION AND INVESTIGATION, PROTRUDING/SHARP EDGES WERE OBSERVED AT THE DEVICE''S DISTAL TIP. THIS EVENT CAPTURES THE TURBO ELITE WITH PROTRUDING/SHARP EDGES, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507186 ↗
• MalfunctionJun 1, 2022Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT''S MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS CHOSEN TO TREAT THE PATIENT. DURING USE IN THE PATIENT, THE DEVICE''S OUTER JACKET HAD SEPARATED AND NO LONGER COVERED THE FIBERS AND INNER LUMEN OF THE CATHETER. A NEW TURBO ELITE OF THE SAME MODEL WAS USED TO SUCCESSFULLY 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 14569216 ↗
• MalfunctionJan 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT'S PROXIMAL COMMON FEMORAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. HOWEVER, UPON REMOVAL OF THE TURBO ELITE DEVICE FROM THE PATIENT'S BODY, THERE WAS A SHEAR/TEAR OBSERVED IN THE CATHETER. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13344850 ↗
• MalfunctionJul 28, 2021Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT'S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. AFTER THE PHYSICIAN HAD USED THE TURBO ELITE DEVICE IN THE PATIENT AND WAS REMOVING THE DEVICE, HE NOTICED THE "INSIDE COMPONENTS OF THE CATHETER WERE COMING OUT OF THE CATHETER". A BALLOON WAS USED TO FINISH THE PROCEDURE, AND THERE WAS NO REPORTED PATIENT HARM. THIS EVENT IS BEING SUBMITTED TO CAPTURE THE TURBO ELITE WHICH WAS FOUND DAMAGED AFTER USE AND RESULTED IN UNINTENDED RADIATION EXPOSURE WITH POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12242946 ↗
• MalfunctionMay 18, 2021Break; Break

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 21 APR 2021 THAT A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2021 TO TREAT A SLIGHTLY CALCIFIED FIBROUS LESION IN THE PATIENT'S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. ACCORDING TO THE PHYSICIAN, THE DEVICE REPORTEDLY "BASICALLY FELL APART" AS SOON AS IT WAS REMOVED FROM THE PACKAGE. IT WAS REPORTED THAT THE OUTER SHEATH COVERING THE DEVICE'S FIBERS WAS TOWN, JUST DISTAL TO THE DEVICE'S RX WIRE EXCHANGE PORT. THE PHYSICIAN STATED TO THE PHILIPS REP THAT THEY NOTICED THE PROBLEM BEFORE IT WENT INTO THE PATIENT, AS THEY WERE PREPPING THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE WITH NO REPORTED PATIENT INJURY. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE DEVICE EVALUATION IS PRESENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11845805 ↗
• InjuryFeb 5, 2021Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) USING A CONTRALATERAL APPROACH. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER AND A 6F COOK MEDICAL INTRODUCER SHEATH WAS USED TO TREAT THIS LESION. ACCORDING TO THE REPORT, THE PHYSICIAN WAS ABLE TO COMPLETE A COUPLE OF LONG RUNS THROUGH THE VASCULATURE WITH PAUSES BETWEEN THE RUNS. AFTER THE ATHERECTOMY WAS COMPLETED AND WHILE THE PHYSICIAN WAS REMOVING`THE TURBO ELITE DEVICE FROM THE PATIENT'S BODY, THE DEVICE REPORTEDLY ''HUNG UP'' WITHIN THE SFA REGION BEFORE REACHING THE COOK MEDICAL INTRODUCER SHEATH. AFTER SOME EFFORT, IT WAS REMOVED FROM THE SFA BUT THEN GOT STUCK IN THE INTRODUCER SHEATH. THE DEVICE WAS ABLE TO BE REMOVED FROM THE INTRODUCER SHEATH BUT THE SHEATH HAD TO BE REPLACED AFTERWARD, AND THE SIZE OF THE INTRODUCER SHEATH WAS INCREASED DUE TO BLEEDING. IT WAS REPORTED THAT THE SFA LOST FLOW DURING THIS TIME, AND A BALLOON WAS USED TO RE-OBTAIN FLOW IN THE SFA. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. VISIBLE DAMAGE TO THE TURBO ELITE DEVICE WAS NOTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND A DEVIC

  Patient problems: Iatrogenic Source; Occlusion; Radiation Exposure, Unintended

  MAUDE report 11285113 ↗
• InjuryDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 19 NOV 2020 THAT A PERIPHERAL ATHERECTOMY PROCEDURE OCCURRED ON (B)(6) 2020 AND A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED (THE REPRESENTATIVE WAS NOT PRESENT AT THE PROCEDURE; THE INFORMATION WAS REPORTED BY THE FACILITY/PHYSICIAN). INDICATION FOR AND LOCATION OF THE PROCEDURE IS UNKNOWN. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN OBTAINED. DURING USE IN THE PATIENT, THE DEVICE'S MARKER BAND BECAME DETACHED WHILE IN THE PATENT'S BODY. THE PHYSICIAN ATTEMPTED TO USE A BALLOON TO RETRIEVE THE MARKER BAND BUT WAS UNSUCCESSFUL; THE BAND REMAINED INSIDE THE BODY AND WAS UNABLE TO BE REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THE MANUFACTURER IS ANTICIPATING THE RETURN OF THE TURBO ELITE DEVICE BACK FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source; No Known Impact Or Consequence To Patient

  MAUDE report 11020606 ↗
• MalfunctionMar 30, 2020Break; Break

  A PERIPHERAL VASCULAR INTERVENTION CASE COMMENCED. THE PHYSICIAN WAS USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER FROM A CONTRALATERAL APPROACH. HE HAD GAINED ACCESS THROUGH THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TARGET A CALCIFIED LESION. DURING THE PROCEDURE, WHILE TRYING TO CROSS THE LESION, IT WAS REPORTED THAT THE TURBO ELITE DEVICE BROKE WHILE IN USE IN THE PATIENT, TREATING HEAVILY CALCIFIED VESSELS. THERE WAS NO REPORTED PATIENT INJURY. IT HAS BEEN REPORTED THAT THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER THIS MAY BE DELAYED DUE TO THE COVID-19 CRISIS. THIS EVENT IS BEING REPORTED AT THIS TIME DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION, ACCORDING TO THE REPORT THE MANUFACTURER HAS BEEN GIVEN.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9901346 ↗
• MalfunctionFeb 10, 2020Material Integrity Problem; Material Integrity Problem

  A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED DUE TO THE PATIENT HAVING VASCULAR DISEASE. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. THE INITIAL REPORT RECEIVED BY THE MANUFACTURER WAS THAT THE GUIDE WIRE WOULD NOT PASS THROUGH THE WIRE LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WAS NO REPORTED PATIENT HARM. HOWEVER, WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, THE DEVICE WAS FOUND TO HAVE A BREACH IN THE DEVICE'S OUTER JACKET. THIS EVENT IS BEING REPORTED 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 9688397 ↗
• MalfunctionDec 10, 2019Fracture; Fracture

  IT WAS REPORTED TO THE MANUFACTURER THAT A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE DEVICE TO USE IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO INSERT, AND SUBSEQUENTLY ENCOUNTERED DIFFICULTY ADVANCING THE DEVICE INTO THE OUTER SHEATH. WHEN THE PHYSICIAN PULLED THE DEVICE OUT OF THE OUTER SHEATH, IT WAS OBSERVED THAT THE TURBO ELITE DEVICE'S OUTER JACKET WAS BREACHED AND FIBERS WERE EXPOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THE DEVICE REPORTEDLY DID NOT ENTER THE PATIENT, NOR WAS LASING ATTEMPTED WITH THE DEVICE. THIS EVENT IS BEING REPORTED 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 9445531 ↗
• InjuryOct 19, 2018Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING AN ATHERECTOMY PROCEDURE TO REMOVE A DE NOVO LESION FROM THE SUPERFICIAL FEMORAL ARTERY (SFA), THE SPECTRANETICS TURBO-ELITE LASER CATHETER 420-159 WAS UTILIZED. THE TURBO-ELITE LASER CATHETER WAS ADVANCED OVER THE 0.014¿ GUIDEWIRE, THROUGH A 6F SHEATH, FROM A PEDAL APPROACH. THE LASER CATHETER ADVANCED WITHOUT ISSUE, BUT THE PHYSICIAN NOTED THAT THE TIP OF THE LASER CATHETER (THE RADIOPAQUE MARKER) WAS MOVING BACK AND FORTH UNDER X-RAY, WHILE HE KEPT THE LASER CATHETER STATIONARY. WHEN HE REMOVED THE LASER CATHETER FROM THE PATIENT IT WAS NOTICED THAT THE RADIOPAQUE MARKER WAS NOT ATTACHED TO TIP OF THE LASER CATHETER, AND WAS STILL ON THE GUIDEWIRE WITHIN THE PATIENT. THE PHYSICIAN ELECTED TO STENT ACROSS THE RADIOPAQUE MARKER TO THE VESSEL WALL. THE RADIOPAQUE MARKER WAS THEN FIXED IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA), AND REMAINED THERE POST PROCEDURE. NO FURTHER INTERVENTION WAS IMPLEMENTED.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 7987513 ↗
• InjurySep 14, 2018Entrapment of Device; Mechanical Problem; Material Separation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Integrity Problem; Entrapment of Device; Mechanical Problem; Material Separation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Integrity Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A PERIPHERAL VASCULAR SURGERY, LEFT ANTERIOR TIBIAL ACCESS WAS USED. DIAGNOSTIC IMAGES WERE TAKEN AND SHOWED SEVERE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) IN-STENT OCCLUSION. THE 80-85% OCCLUSIONS OF SOFT PLAQUE WERE FOUND THROUGHOUT THE STENT, WITH SOME CALCIUM NOTED IN THE PROXIMAL SECTION OF STENT. THE SPECTRANETICS 2.0 TURBO-ELITE CATHETER (420-159) WAS OPENED AND PREPPED WITHOUT ISSUE. THE 2.0 TURBO-ELITE CATHETER (420-159) WAS SUCCESSFULLY ADVANCED TO THE DISTAL PART OF THE STENT AND PASSED SMOOTHLY. AFTER THE FIRST PASS OF ABOUT 20 SECONDS LASER TIME AND ABOUT 30CM ADVANCEMENT, IT WAS NOTICED THAT THE DISTAL TIP OF THE LASER CATHETER WAS NO LONGER VISIBLE ON THE IMAGING. THE LASER WAS REMOVED AND THE METAL RADIOPAQUE RING WAS FOUND TO BE IN THE POPLITEAL ARTERY OFF THE WIRE AND WEDGED IN A SIDE BRANCH OF THE POPLITEAL ARTERY. THE PHYSICIAN WAS UNABLE TO MANIPULATE THE METAL RING WITH ASPIRATION OR BALLOON THERAPY. THE PHYSICIAN DECIDED THAT THE METAL RING WAS "STUCK" IN THE POPLITEAL SIDE BRANCH AND THAT IT WOULD BE LEFT IN PLACE. THEY OPENED ANOTHER 2.0 TURBO-ELITE CATHETER AND FINISHED LASING THE REST OF THE SFA STENT WITHOUT IN

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 7879224 ↗
• MalfunctionAug 28, 2018Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  A PROCEDURE COMMENCED TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY LESION. IT WAS NOTED THAT THE LESION WAS NOTED TO BE PLAQUE. ONCE THE LASER CATHETER GOT THROUGH THE LESION, THE CATHETER WAS PULLED BACK, AND IT WAS NOTED THAT THE MARKER BAND HAD DETACHED FROM THE DISTAL TIP OF THE DEVICE, AND WAS STILL PRESENT ON THE WIRE. THE TEAM USED A BALLOON TO RETRIEVE THE MARKER BAND. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH EXCELLENT RESULT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825199 ↗