Turbo-Elite Laser Atherectomy CatheterRecalls & reported problems across all models
Spectranetics Corporation · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Turbo-Elite Laser Atherectomy Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 132
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 2
We found 12 models of Turbo-Elite Laser Atherectomy Catheter by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2018 and May 15, 2026 — classified as 31 injuries, 101 malfunctions.
The most frequently reported specific device problem is “Material Separation” (39 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Turbo-Elite Laser Atherectomy Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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 · names 7 of these models · Recall details · FDA record ↗
- 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 · names 4 of these models · Recall details · FDA record ↗
Most reported Turbo-Elite Laser Atherectomy Catheter problems
Device problems
- Material Separation39
- Break26
- Detachment of Device or Device Component17
- Adverse Event Without Identified Device or Use Problem16
- Material Deformation10
- Material Puncture/Hole7
- Material Split, Cut or Torn6
- Entrapment of Device5
Patient problems
- Unintended Radiation Exposure59
- No Clinical Signs, Symptoms or Conditions38
- Radiation Exposure, Unintended26
- Iatrogenic Source13
- No Known Impact Or Consequence To Patient8
- Device Embedded In Tissue or Plaque4
- Embolism/Embolus3
- Vascular Dissection3
Turbo-Elite Laser Atherectomy Catheter models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Turbo-Elite Laser Atherectomy Catheter 420-006Catheter, Peripheral, Atherectomy2 recalls19 reports
- Turbo-Elite Laser Atherectomy Catheter 417-152Catheter, Peripheral, Atherectomy2 recalls16 reports
- Turbo-Elite Laser Atherectomy Catheter 414-151Catheter, Peripheral, Atherectomy1 recall22 reports
- Turbo-Elite Laser Atherectomy Catheter 420-159Catheter, Peripheral, Atherectomy1 recall17 reports
- Turbo-Elite Laser Atherectomy Catheter 423-001Catheter, Peripheral, Atherectomy1 recall14 reports
- Turbo-Elite Laser Atherectomy Catheter 414-159Catheter, Peripheral, Atherectomy1 recall7 reports
- Turbo-Elite Laser Atherectomy Catheter 423-135-01Catheter, Peripheral, Atherectomy1 recall2 reports
- Turbo-Elite Laser Atherectomy Catheter 425-011Catheter, Peripheral, Atherectomy1 recall0 reports
- Turbo-Elite Laser Atherectomy Catheter 425-135-01Catheter, Peripheral, Atherectomy1 recall0 reports
- Turbo-Elite Laser Atherectomy Catheter 410-152Catheter, Peripheral, Atherectomy24 reports
- Turbo-Elite Laser Atherectomy Catheter 410-154Catheter, Peripheral, Atherectomy7 reports
- Turbo-Elite Laser Atherectomy Catheter 417-156Catheter, Peripheral, Atherectomy4 reports
Recent Turbo-Elite Laser Atherectomy Catheter adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗MalfunctionMar 24, 2026Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH USE OF A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING USE, THE LASER BURNED THROUGH THE OUTER JACKET. THE CATHETER WAS REMOVED AND A 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 24680033 ↗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 ↗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 ↗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 ↗MalfunctionOct 29, 2025Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION USING A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING USE, EXPOSED FIBERS AND A COMPROMISED OUTER JACKET WERE OBSERVED. THE TURBO-ELITE WAS REMOVED AND A NEW DEVICE 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 23414418 ↗MalfunctionOct 17, 2025Entrapment of Device; Entrapment of Device
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH A NON-PHILIPS GUIDEWIRE AND NON-PHILIPS INTRODUCER SHEATH, WERE USED TO TREAT THE PATIENT. DURING USE, THE TURBO-ELITE BECAME STUCK IN THE INTRODUCER SHEATH; THEREFORE, THE TURBO-ELITE AND INTRODUCER SHEATH WERE REMOVED TOGETHER. A NEW TURBO-ELITE AND INTRODUCER SHEATH 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 23327733 ↗MalfunctionOct 15, 2025Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY FIBROUS LESION IN THE MID ARTERIAL TIBIAL (AT) ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE CATHETER COULD NOT BE RECALIBRATED AFTER THE SECOND RUN. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 18SEP2025: VISUAL INSPECTION FOUND HEAVY BIOLOGICS, CHIPPED FIBERS AND EPOXY, ALONG WITH MISSING FIBERS AND EPOXY AT THE TURBO-ELITE DISTAL TIP. ON THE PROXIMAL END OF THE CATHETER, OVER HALF OF THE FIBERS WERE NON-FUNCTIONING; THEREFORE, UNABLE TO PERFORM CALIBRATION. THIS REPORT CAPTURES THE TURBO-ELITE WITH MISSING MATERIAL; POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23305967 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER TREATMENT, IMAGING SHOWED WHAT APPEARED TO BE DISLODGED PLAQUE THAT HAD EMBOLIZED. A FILTER AND BALLOON WERE PLACED TO CAPTURE THE EMBOLISM, AND THE FILTER WAS REMOVED FROM THE PATIENT. AT THIS TIME, IT WAS NOTICED THAT THERE WAS FURTHER EMBOLIZATION IN THE TIBIOPERONEAL (TP) TRUNK; THEREFORE, A MEDTRONIC SPIDERFX EMBOLIC PROTECTION DEVICE WAS USED TO CAPTURE AND REMOVE THE EMBOLISM. ONCE REMOVED, THE TP VESSELS WERE FILLING PROPERLY. HOWEVER, LATER THAT WEEK, THE PATIENT RETURNED FOR FOLLOW-UP, AND ULTRASOUND DETECTED THAT THE PATIENT HAD RE-OCCLUSION, WHICH WAS LARGER THAN THE ORIGINAL TREATMENT SITE. THE PEDAL VESSELS WERE SHOWING VERY LITTLE BLOOD FLOW; THUS, A STENT WAS PLACED, AND THE PATIENT WAS SCHEDULED FOR SURGERY AT A LATER DATE. THIS REPORT CAPTURES THE TURBO-ELITE IN USE IN THE AREA WHERE AN EMBOLISM AND RE-OCCLUSION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN
Patient problems: Embolism/Embolus; Obstruction/Occlusion
MAUDE report 22973734 ↗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 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHILE LASING THROUGH THE LESION, RESISTANCE WAS ENCOUNTERED, AND A CRACK JUST BEYOND THE FLUSH PORT WAS OBSERVED, WITH RED LASER LIGHT EMITTING. THE TURBO-ELITE WAS REMOVED AND A NEW DEVICE 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 22834161 ↗MalfunctionJul 7, 2025Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE DISTAL TIP OF THE CATHETER APPEARED CHARRED; THEREFORE, THE DEVICE WAS REMOVED, AND THE CASE WAS ABORTED WITH NO REPORTED PATIENT HARM. THE PATIENT WILL BE SCHEDULED TO HAVE BYPASS DUE TO PATIENT CONDITION (SEVERE CTO). UPON DEVICE EVALUATION ON (B)(6) 2025, VISUAL INSPECTION OF THE TURBO-ELITE FOUND MISSING AND CHARRED EPOXY, WITH CHIPPED FIBERS AT THE DISTAL TIP. THIS REPORT CAPTURES THE TURBO-ELITE WITH MISSING MATERIAL, POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22421422 ↗
Other Spectranetics Corporation products
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- LLD #2 Lead Locking Device2 models · 72 reports
- AngioSculpt PTCA RX Scoring Balloon Catheter8 models · 55 reports
- ELCA Coronary Laser Atherectomy Catheter4 models · 42 reports
- TightRail Sub-C Rotating Dilator Sheath3 models · 32 reports
- Stellarex8 models · 27 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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