Turbo-Elite Laser Atherectomy Catheter 417-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00813132024734), received between Feb 21, 2020 and Feb 3, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 FDA recall records name this device's identifier, 2 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 25, 2024Class IIOpen, Classified

   Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

   Z-0680-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Separation; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHT PLAQUE LESION IN THE MID TIBIOPERONEAL (TP) TRUNK. DURING USE OF A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, A HOLE IN THE OUTER JACKET WITH LASER LIGHT EMITTING WAS OBSERVED NEAR THE TIP. THE CATHETER WAS REMOVED AND NEW TURBO-ELITE 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 24250685 ↗
• MalfunctionOct 29, 2025Entrapment of Device; Entrapment of Device

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH A NON-PHILIPS GUIDEWIRE WERE BEING USED TO TREAT THE PATIENT. UPON REMOVAL FROM THE PACKAGING, IT WAS NOTED THAT THE TURBO-ELITE WAS TWISTED AND CRIMPED. WHEN ATTEMPTING TO LOAD THE DEVICE OVER THE GUIDEWIRE, THE TURBO-ELITE BECAME STUCK ON THE GUIDEWIRE; THEREFORE, REMOVED TOGETHER. A NEW TURBO-ELITE AND GUIDEWIRE WERE USED, AND THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414981 ↗
• MalfunctionApr 11, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  THIS EVENT IS NO LONGER REPORTABLE FOR UNINTENDED RADIATION EXPOSURE - POTENTIAL FOR HARM. PER THE RETURNED DEVICE ANALYSIS, NO BREACH TO THE OUTER JACKET WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 19089708 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF A MODERATELY CALCIFIED FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHEN THE PROCEDURE WAS COMPLETED AND THE TURBO-ELITE WAS REMOVED, THE PHYSICIAN NOTICED THE TIP OF THE CATHETER WAS CHARRED AND DISCOLORED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. DURING DEVICE EVALUATION, THE OUTER JACKET WAS FOUND MELTED AND BREACHED NEAR THE DISTAL TIP. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18489718 ↗
• MalfunctionDec 1, 2023Material Separation; Material Deformation; Material Separation; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE MID TIBIOPERONEAL (TP) TRUNK. A SPECTRANETICS 1.7 TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, IT WAS REPORTED THAT THE OUTER JACKET WAS COMPROMISED, WITH LASER LIGHT SEEN EXITING THE SIDE OF THE CATHETER. USE OF THE TURBO-ELITE WAS DISCONTINUED, AND A NEW CATHETER WAS USED TO COMPLETE THE CASE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 18249182 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS PART OF A POSTMARKET STUDY BEING CONDUCTED IN (B)(6). A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT AN IN-STENT REOCCLUSION (ISR) IN THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY. INITIALLY, ON (B)(6) 2020, THE ISR WAS SUCCESSFULLY TREATED WITH A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER AND NON-COATED BALLOON CATHETER. HOWEVER, ON (B)(6) 2021, ISR WAS AGAIN CONFIRMED WITH NO TREATMENT RECOMMENDED AT THIS TIME. THEN, ON (B)(6) 2021, IT WAS CONFIRMED THAT THE PATIENT¿S HEALTH DID NOT IMPROVE. THE PHYSICIAN THOUGHT THERE WAS NO RELATION BETWEEN THE ISR AND THE TURBO ELITE AND THE PROCEDURE. APPROXIMATELY TWO WEEKS LATER ON (B)(6) 2021, THE LESION WAS TREATED WITH A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER AND A JADE 5.0MM BALLOON. AN IVUS CATHETER WAS IN USE DURING THE PROCEDURE. FOUR DAYS LATER ON (B)(6) 2021, ACUTE LIMB ISCHEMIA DUE TO ARTERIAL THROMBUS WAS CONFIRMED. FINALLY ON (B)(6) 2021, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED WITH USE OF PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TURBO ELITE DEVICE IN USE ON (B)(6) 2021

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 13553111 ↗
• InjuryNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE PATIENT'S DISTAL POPLITEAL ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE DEVICE'S DISTAL MARKER BAND BECAME DETACHED WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE MARKER BAND WITH A SNARE, BUT WAS UNSUCCESSFUL. THE MARKER BAND WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT USING A QUICKCLEAR DEVICE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO ELITE DEVICE IN USE WHEN ITS MARKER BAND DETACHED WITHIN THE PATIENT, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791106 ↗
• MalfunctionAug 18, 2021Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE HOUSING OF THE CATHETER WAS BROKEN; WHEN THEY INSERTED THE CATHETER THEY COULD SEE RED LIGHT EMITTING THROUGH THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A SECOND TURBO ELITE DEVICE WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO ELITE WHICH WAS REPORTED DAMAGED DURING USE AND RESULTED IN UNINTENDED RADIATION EXPOSURE WITH POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12339190 ↗
• MalfunctionJun 30, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO A PHILIPS REPRESENTATIVE ON 09 JUNE 2021 THAT PREPARATIONS WERE COMMENCING FOR A PERIPHERAL ATHERECTOMY PROCEDURE TO BEGIN ON (B)(6) 2021. IT WAS REPORTED THAT A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS BEING CALIBRATED. DURING CALIBRATION, THE CATHETER REPORTEDLY BECAME SO HOT THAT IT MADE A HOLE IN THE TECHNICIAN'S GLOVE, BUT REQUIRED NO MEDICAL ATTENTION. THIS EVENT IS BEING CONSERVATIVELY REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION, BASED UPON THE DESCRIPTION PROVIDED IN THE COMPLAINT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12096315 ↗
• MalfunctionJun 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021 A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED. IT WAS REPORTED THAT THE PHYSICIAN WAS IN A TORTUOUS VESSEL USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DEVICE'S DISTAL MARKER BAND DETACHED ONTO THE GUIDE WIRE. THE MARKER BAND WAS ABLE TO BE RETRIEVED SUCCESSFULLY AND THERE WAS NO REPORTED PATIENT HARM. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11976193 ↗
• MalfunctionMay 11, 2021Crack; Crack

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO PROVIDE TREATMENT TO THE PATIENT'S SUPERFICIAL FEMORAL ARTERY(SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE WITHIN THE PATIENT, RED LIGHT WAS SEEN EMITTING FROM THE SIDE OF THE CATHETER. IT WAS REPORTED THERE WAS A CRACK IN THE CATHETER; HOWEVER, THE PHYSICIAN WAS UNSURE OF THE EFFICACY OF THE DEVICE. THE TURBO ELITE DEVICE WAS REPORTEDLY USED TO COMPLETE THE PROCEDURE 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 TURBO ELITE CATHETER FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 11807090 ↗
• MalfunctionMay 11, 2021Crack; Crack

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO PROVIDE TREATMENT TO THE PATIENT'S SUPERFICIAL FEMORAL ARTERY(SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE WITHIN THE PATIENT, RED LIGHT WAS SEEN EMITTING FROM THE SIDE OF THE CATHETER. IT WAS REPORTED THERE WAS A CRACK IN THE CATHETER; HOWEVER, THE PHYSICIAN WAS UNSURE OF THE EFFICACY OF THE DEVICE. THE TURBO ELITE DEVICE WAS REPORTEDLY USED TO COMPLETE THE PROCEDURE 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 TURBO ELITE CATHETER FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 11807072 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED TO A PHILIPS SALES REPRESENTATIVE (NOT PRESENT AT THE PROCEDURE) FROM THE FACILITY/PHYSICIAN ON (B)(6) 2021 THAT A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2021 TO TREAT A SLIGHTLY CALCIFIED SOFT TISSUE LESION USING A RETROGRADE ACCESS APPROACH. THE INDICATION FOR THIS PROCEDURE OR THE LESION LOCATION WAS UNAVAILABLE TO THE MANUFACTURER. ACCORDING TO THE REPORT, THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT, AND AFTER CALIBRATING THE DEVICE AND PRIOR TO PUTTING IT INTO THE PATIENT'S BODY, LIGHT WAS NOTICED SHINING OUT FROM THE TUBING OF THE DEVICE. THEY REMOVED THE DEVICE FROM THE LASER SYSTEM AND OPENED A SECOND LASER CATHETER. THE PROCEDURE WAS THEN COMPLETED WITHOUT EVENT AND THE PATIENT SURVIVED WITH NO REPORTED INJURY. THE DEVICE WAS DISCARDED AT THE FACILITY AND THEREFORE IS NOT AVAILABLE FOR EVALUATION. 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: Unintended Radiation Exposure

  MAUDE report 11602157 ↗
• InjuryMar 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY FIBROUS LESION IN THE MID PERONEAL ARTERY USING A CONTRALATERAL APPROACH. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER. IT WAS REPORTED THAT DURING PULLBACK, WITH THE TURBO ELITE DEVICE LASING, THE DEVICE'S DISTAL RADIOPAQUE MARKER BAND DETACHED FROM THE DEVICE WITHIN THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT LASING IN THE PRESENCE OF CONTRAST MEDIUM, AND THE DEVICE WAS FLUSHED PER THE SPECTRANETICS INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN USED A MEDTRONIC BALLOON TO SUCCESSFULLY REMOVE THE MARKER BAND FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE MANUFACTURER IS ANTICIPATING RETURN OF THE TURBO ELITE DEVICE FOR EVALUATION, BUT HAS NOT YET RECEIVED IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11416346 ↗
• MalfunctionJul 22, 2020Collapse; Degraded; Collapse; Degraded

  A PHILIPS REPRESENTATIVE WAS INFORMED OF THIS EVENT ON (B)(6) 2020. A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO), SEVERELY CALCIFIED LESION (LOCATION OF LESION UNKNOWN). CROSSING THE LESION WAS MADE BY ACCESSING FROM FEM CTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS CHOSEN FOR THE PROCEDURE. AS THE PHYSICIAN WAS LASING, HE CAME UPON A HEAVILY CALCIFIED AREA THAT WAS DIFFICULT TO CROSS. AS HE GRIPPED THE FIBER NEAR THE SHEATH BEING USED IN THE PROCEDURE, THE FIBER REPORTEDLY BUCKLED AGAINST THE SHEATH AND HE NOTICED THAT A SMALL PORTION OF THE DEVICE'S OUTER JACKET CAME OFF OF THE LASER CATHETER AND RED LIGHT WAS SLIGHTLY VISIBLE. AT THAT TIME, THE LASER CATHETER WAS REPORTEDLY REMOVED AND THE CASE WAS COMPLETED WITH A BALLOON. IT WAS REPORTED THAT THE LASER CATHETER WAS NOT BROKEN, JUST BUCKLED, AND THE PORTION OF THE DEVICE'S OUTER JACKET CAME OFF OF WHERE THE PHYSICIAN WAS HOLDING THE FIBER BEFORE IT ENTERS THE SHEATH. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT INJURIES. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERG

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10311317 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED. THE PHYSICIAN WAS USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT A LEFT POPLITEAL LESION FROM A PEDAL ACCESS SITE. THE LASER IMPACTED THE DISTAL CAP OF THE OCCLUSION; HOWEVER, INSTEAD OF CROSSING THE LESION, THE TURBO ELITE UNINTENTIONALLY DEFLECTED OFF OF THE PLAQUE AND CREATED A SUBINTIMAL CHANNEL WHICH THEN WENT SUBMEDIAL. THE CASE WAS THEN ABORTED WITH NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES USED IN THE PROCEDURE. UPON FURTHER INVESTIGATION OF THIS EVENT AND WITH CONSULTATION FROM PHILIPS SENIOR MEDICAL ADVISOR ON (B)(6) 2020 TO DISCUSS THE CASE DETAIL OF SUBINTIMAL AND SUBMEDIAL CHANNELS BEING CREATED BY THE TURBO ELITE DEVICE, IT WAS CONCLUDED THAT ALTHOUGH THERE ARE PROCEDURES PERFORMED IN WHICH CHANNELS ARE CREATED IN THIS VESSEL SPACE IN ORDER TO RESTORE BLOOD FLOW, THIS WAS AN UNPLANNED EVENT. ALTHOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT, THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THIS EVENT WAS TO RECUR.

  Patient problems: Iatrogenic Source; Intimal Dissection

  MAUDE report 9742168 ↗