Turbo-Elite Laser Atherectomy Catheter 423-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00813132024772), received between May 21, 2020 and Sep 3, 2025 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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 ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING USE OF THE SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, A CALIBRATION ERROR CODE WAS PRESENT. THE PHILIPS SYSTEM WAS RESTARTED, BUT CALIBRATION OF THE CATHETER WAS UNSUCCESSFUL. THEREFORE, THE TURBO-ELITE WAS REMOVED AND A BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. UPON DEVICE EVALUATION, VISUAL INSPECTION FOUND A BREACH IN THE JACKET 64 MM FROM THE DISTAL END OF THE BIFURCATE COVER. IN THE AREA OF THE BREACH, THE OUTER JACKET APPEARS TORN; HOWEVER, NO BROKEN FIBERS OR MELTING/CHARRING TO THE OUTER JACKET WAS VISIBLE. FUNCTIONAL TESTING FOR DEVICE CALIBRATION WAS NOT ATTEMPTED DUE TO THE BREACH IN THE JACKET, THUS THE ERROR MESSAGE COULD NOT BE CONFIRMED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22953531 ↗
• MalfunctionJun 11, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH A 0.014 GUIDEWIRE (MANUFACTURER UNKNOWN), WAS USED TO TREAT THE PATIENT. DURING USE, THE GUIDEWIRE COULD NO LONGER BE ADVANCED; THEREFORE, BY CHOICE, THE TURBO-ELITE AND GUIDEWIRE WERE REMOVED AS A SYSTEM. UPON REMOVAL, LASER LIGHT WAS NOTED COMING FROM THE SIDE OF THE CATHETER. THE GUIDE WIRE WAS REMOVED FROM THE TURBO-ELITE AND A NEW TURBO-ELITE WAS USED WITH THE EXISTING GUIDE WIRE. TREATMENT WAS COMPLETE AND THERE WAS NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

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

  MAUDE report 22185608 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF A JAPAN TURBO POSTMARKET STUDY, A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT AN IN-STENT RESTENOSIS (ISR) IN THE PATIENT''S LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER (ALONG WITH NON-DRUG COATED AND DRUG COATED BALLOON CATHETERS, AND A STENT GRAFT). AFTER USE OF THE TURBO ELITE, ANGIOGRAPHY FINDINGS SHOWED THROMBOSIS. THE THROMBOSIS WAS NOT TREATED AND THE PHYSICIAN COMPLETED THE PROCEDURE USING A PLAIN OLD BALLOON ANGIOPLASTY (POBA). IT IS UNK WHERE THE THROMBOSIS ORIGINATED, AND IT WAS NOT CONFIRMED WHETHER THROMBOSIS WAS PRESENT PRE-PROCEDURE. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION, CAPTURING THE TURBO ELITE DEVICE WHICH WAS BEING USED WHEN THROMBOSIS WAS DISCOVERED. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO ELITE DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 15888078 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PATIENT'S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. THE DEVICE WAS PREVIOUSLY USED IN THE PATIENT'S COMMON FEMORAL ARTERY (CFA) BEFORE USE WITHIN THE SFA. WHILE THE TURBO ELITE DEVICE WAS TREATING THE LESION WITHIN THE SFA, THE DEVICE'S DISTAL MARKER BAND DETACHED WITHIN THE PATIENT VASCULATURE. THE MARKER WAS RETRIEVED USING A FILTER AND A SNARE. ANOTHER TURBO ELITE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT SURVIVED WITH NO REPORTED 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 14279715 ↗
• InjuryJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED LESION IN THE PATIENT'S MID POPLITEAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DEVICE'S MARKER BAND DETACHED AND WAS SUCCESSFULLY RETRIEVED USING A BALLOON. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE 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 13361334 ↗
• InjuryDec 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT AN IN-STENT RESTENOSIS (ISR) ON A SLIGHTLY CALCIFIED PLAQUE LESION IN THE PATIENT'S MID POPLITEAL ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE, THE DEVICE'S DISTAL MARKER BAND SEPARATED INSIDE THE BODY. THE PHYSICIAN USED A BALLOON TO SUCCESSFULLY RETRIEVE THE MARKER BAND AND REMOVE IT. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE 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 13022539 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, INCLUDED AS PART OF A (B)(6) POSTMARKET STUDY. THE PROCEDURE WAS AN IN-STENT RESTENOSIS (ISR) TO TREAT A LESION IN THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER AND A DRUG COATED BALLOON CATHETER TO TREAT THE PATIENT. AFTER THE PROCEDURE, A GRADE B ARTERIAL DISSECTION WAS OBSERVED AFTER USE OF THE TURBO ELITE, AND OBSERVED ALSO AFTER USE OF THE BALLOON. THERE WAS NO NEED FOR INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED THREE DAYS LATER WITH NO FURTHER COMPLICATIONS. THIS REPORT CAPTURES THE TURBO ELITE DEVICE IN USE WHEN THE ARTERIAL DISSECTION OCCURRED, WITH NO INTERVENTION REQUIRED. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO ELITE DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 13022388 ↗
• InjuryJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 14 JUNE 2021 OF A PERIPHERAL ATHERECTOMY PROCEDURE, PERFORMED (B)(6) 2021 IN WHICH THE PHYSICIAN USED A SPECTRANETICS 2.3 TURBO ELITE LASER ATHERECTOMY CATHETER. ALTHOUGH THE REPRESENTATIVE WAS NOT AT THE PROCEDURE, IT WAS REPORTED THAT TREATMENT OF A STENOSIS OR LESION WAS BEING PERFORMED IN A MODERATELY FIBROUS AREA IN THE POPLITEAL ARTERY. AT THE TIME OF THE (B)(6) PROCEDURE, THERE WERE NO REPORTED ISSUES AND THE PROCEDURE WAS COMPLETED. HOWEVER, AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT''S SYMPTOMS DID NOT RESOLVE AND SO A DUPLEX SCAN WAS PERFORMED. THE SCAN SHOWED "SOMETHING HAD SHUT DOWN", BUT THEY WERE NOT SURE WHAT, SO A SUBSEQUENT PROCEDURE WAS PERFORMED ON (B)(6) 2021. IN THIS PROCEDURE ON (B)(6), THE PHILIPS REPRESENTATIVE WAS PRESENT AT THE PROCEDURE. IT AS IDENTIFIED THAT THE TURBO ELITE 2.3 DEVICE''S DISTAL MARKER BAND HAD REPORTEDLY DETACHED DURING THE PROCEDURE ON (B)(6), NOT DISCOVERED AT THAT TIME, AND DURING THE FIRST FLUOROSCOPIC IMAGES TAKEN DURING THE (B)(6) PROCEDURE, THE MARKER BAND WAS CONFIRMED TO BE PRESENT IN THE PATIENT''S POPLITEAL ARTERY. THE PHYSICIAN UTILIZED A SPECTRANETICS QUICK-CROSS SUPPORT CA

  Patient problems: Foreign Body Embolism

  MAUDE report 12163477 ↗
• MalfunctionJul 13, 2021Break; Break

  THIS EVENT IS NO LONGER REPORTABLE FOR POTENTIAL EXPOSURE TO MANUFACTURING MATERIALS AND UNINTENDED RADIATION EXPOSURE. PER THE RETURNED DEVICE ANALYSIS, NO BREACH IN THE DEVICE''S OUTER JACKET WAS DETECTED. THIS EVENT DID NOT RESULT IN PATIENT HARM NOR WOULD IT CAUSE OR CONTRIBUTE TO PATIENT HARM WITH RECURRENCE.

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

  MAUDE report 12158927 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS (B)(6) REPRESENTATIVE BECAME AWARE ON 01 JUNE 2021 THAT A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2021 TO TREAT AN IN-STENT OCCLUSION IN THE PROXIMAL, MID AND DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) IN THE PATIENT''S LEFT LOWER EXTREMITY. THIS EVENT WAS PART OF A POSTMARKET STUDY OCCURRING IN JAPAN. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS REPORTED THAT LESION WAS PRESENT IN THE VESSEL PROXIMAL AND DISTAL TO THE STENT, AS WELL AS BEING PRESENT IN THE STENT ITSELF. IT WAS REPORTED THAT THE TURBO ELITE DEVICE SUCCESSFULLY LASED THROUGH THE LESION, CLEARING THE OBSTRUCTION. HOWEVER, IT WAS REPORTED THAT AFTER THE TURBO ELITE DEVICE WAS USED, AN ACUTE OCCLUSION WAS CONFIRMED ON ANGIOGRAM; THE REPORT STATED THAT THE BLOOD VESSELS RECOILED AFTER APPLYING THE TURBO ELITE DEVICE TO THE IN-STENT LESION. THE OBSTRUCTIVE LESION OUTSIDE THE STENT HAD NOT BEEN DILATED AT THAT TIME, AND AN INFLUX OF CONTRAST MEDIUM WAS THEN PRESENT WITHIN THE SFA, AND NO LASER BASED BLOOD FLOW WAS PRESENT ON THE ANGIOGRAM IMAGE. A WIRE WAS THEN PASSED THROUGH TO THE OCCLUSION REPORTEDLY OUTSIDE THE BLOOD VE

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 12096044 ↗
• MalfunctionMay 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION WITHIN AN EXISTING STENT IN A POPLITEAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS REPORTED THAT ON THE 3RD PASS THROUGH THE LESION WITH THE CATHETER, THE DEVICE'S DISTAL MARKER BAND DISLODGED WITHIN THE PATIENT''S POPLITEAL ARTERY. THE MARKER BAND WAS SUCCESSFULLY REMOVED BY USING A BALLOON. THERE WAS NO REPORTED PATIENT HARM. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INITIAL DEVICE EVALUATION IS CAPTURED WITHIN SECTION 10./11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896296 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED INFORMATION RECEIVED FROM JOURNAL ARTICLE (JACC: CARDIOCASCULAR INTERVENTIONS, VOL. 14, NO. 23, 2021) ON 15NOV2022: THE PATIENT UNDERWENT THE PROCEDURE FOR IN-STENT OCCLUSION (ISO). THE GUIDE WIRE SUPPORTED WITH A MICROCATHETER ENTERED THE PROXIMAL ISO BUT COULD NOT ADVANCE ANY FURTHER DUE TO HARD PLAQUE. THE TURBO ELITE ADVANCED SLOWLY, BUT WAS UNABLE TO PASS THE STENTS'' OVERLAPPED AREA DUE TO RESISTANCE. USING A ZEMPORSHE OVALIS ANGIOSCOPE AND A PHILIPS VISION PV .018 IVUS CATHETER, AN ARTERIAL PERFORATION AND RUPTURE WAS IDENTIFIED IN THE TISSUE COVERING THE STENT, DUE TO USE OF THE TURBO ELITE. HEMOSTASIS AND SUCCESSFUL RECANALIZATION WAS ACHIEVED WITH IMPLANTATION OF AN ENDOVASCULAR STENT GRAFT.

  Patient problems: Iatrogenic Source; Perforation; Perforation of Vessels; Rupture

  MAUDE report 11055418 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE OCCLUSION IN THE PATIENT'S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A STENT WAS REPORTEDLY PRESENT IN PATIENT'S SFA REGION PRIOR TO THE PROCEDURE, AND THE CONDITION OF THE LESION WITHIN THE PATIENT'S VASCULATURE WAS REPORTED TO BE IN POOR CONDITION. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO PERFORM THE PROCEDURE. TO START THE PROCEDURE, THE PHYSICIAN USED AN IPSILATERAL ACCESS. HOWEVER, THE LESION WAS FOUND TO BE VERY TIGHT (SEVERELY NARROWED) AT THE PROXIMAL SFA REGION. ATTEMPT WAS THEN MADE TO ACCESS THE LESION FROM A RETROGRADE APPROACH, ENTERING FROM THE POPLITEAL ARTERY IN ORDER TO CROSS THE LESION. THE PHYSICIAN FINALLY COULD CROSS TO 1CM FROM THE STENT'S DISTAL EDGE, USING A KNUCKLE WIRE TECHNIQUE WITH 0.035" GUIDE WIRE. AFTERWARD, USING A MICROCATHETER AND OTHER INTERVENTIONS, THE 0.035" GUIDE WIRE COULD CROSS TO POPLITEAL. THEN, A 0.014" GUIDE WIRE WAS USED AND THE LESION WAS ABLE TO BE CROSSED WITH USE OF THE TURBO ELITE DEVICE TWO TIMES. AFTERWARD, A DRUG COATED BALLOON WAS USED, DILATED, AND COMPLETED THE PROCEDURE WITH NO REPORTED PATIENT HARM. HOWEVER, ON 18

  Patient problems: Occlusion

  MAUDE report 10484131 ↗
• MalfunctionMay 21, 2020Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER DEVICE. ALTHOUGH REQUESTED, PROCEDURE INDICATION IS UNAVAILABLE FROM THE FACILITY. DURING PREPARATION FOR USE WITH THE TURBO ELITE, THE PHYSICIAN REPORTED THAT THE DEVICE FAILED CALIBRATION. THE PHYSICIAN THEN SAW LIGHT LEAKING OUT OF THE DEVICE APPROXIMATELY ONE THIRD FROM THE PROXIMAL END OF THE DEVICE. 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. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURE MATERIALS AND INADVERTENT LASER ENERGY/RADIATION EXPOSURE.

  Patient problems: Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 10081033 ↗