Turbo-Power Laser Atherectomy Catheter 420-050 (UDI 00813132026783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132026783), received between May 9, 2022 and Mar 8, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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.

• MalfunctionMar 8, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO USE OF SPECTRANETICS DEVICES, MULTIPLE TOOLS (COOK MEDICAL 6F INTRODUCER SHEATH, BD ROTAREX EXCISIONAL ATHERECTOMY SYSTEM) WERE USED TO BEGIN THE PROCEDURE. PER REPORT, THE ROTAREX DISTAL TIP BROKE OFF INSIDE THE COOK SHEATH, AND A SNARE WAS USED TO REMOVE THE SEPARATED PORTION. THEN, A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER WAS LOADED OVER A GUIDE WIRE AND INSERTED THROUGH THE SAME COOK SHEATH. AFTER TREATMENT AND DURING REMOVAL, THE TURBO-POWER WAS STUCK WITHIN THE SHEATH, NECESSITATING REMOVAL AS A UNIT. UPON OBSERVATION, EXPOSED FIBERS AND SEPARATION OF THE CATHETER WERE NOTED. IN ADDITION, THE COOK SHEATH''S COILS/BRAIDS WERE LOOSE AND UNRAVELED, BOUND AGAINST THE TURBO-POWER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING SUBMITTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18867892 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2023 (AS PART OF A JAPAN TURBO PMS STUDY) TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT HAD A LARGE AMOUNT OF BASELINE BLOOD CLOTS/THROMBOSIS PRESENT PRIOR TO THE PROCEDURE. MULTIPLE DEVICES (GUIDE WIRE, INTRODUCER SHEATH, GUIDE CATHETER, SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER, NON-DRUG COATED AND DRUG-COATED BALLOONS) WERE USED DURING THE PROCEDURE. HOWEVER, JUST AFTER USE OF THE TURBO-POWER CATHETER, EMBOLIZATION WAS CONFIRMED AT THE POPLITEAL ARTERY VIA ANGIOGRAM. THE THROMBUS WAS ASPIRATED WITH USE OF A THROMBO-ASPIRATION CATHETER, WITH REVASCULARIZATION CONFIRMED AFTERWARDS. THE ANGIOGRAM SHOWED NOTHING AFTER USE OF PLAIN OLD BALLOON ANGIOPLASTY (POBA), AND STENOSIS IMPROVED FROM 100% TO 50%. THE PATIENT SURVIVED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. PER PHILIPS PHYSICIAN ASSESSMENT, EMBOLIZATION OF BASELINE THROMBUS CAN OCCUR WHEN ANY DEVICE IS MANIPULATED THROUGH THE THROMBUS, INCLUDING A WIRE, LASER CATHETER OR BALLOON. THIS REPORT CAPTURES THE TURBO-POWER CATHETER WHEN, AFTER USE, EMBOLIZATION WAS DISCOVERED VIA ANGIOGR

  Patient problems: Embolism/Embolus

  MAUDE report 18455746 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED, FIBROUS LESION IN THE MID PEDAL ARTERY. A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING THE PROCEDURE, LASER LIGHT WAS OBSERVED EMITTING FROM THE MID PORTION OF THE CATHETER SHAFT. USE OF THE TURBO-POWER 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 18144229 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2023 (AS PART OF A JAPAN TURBO PMS STUDY) TO TREAT A 100% OCCLUDED LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A DISTAL EMBOLIC PROTECTION DEVICE WAS PLACED WITHIN THE PATIENT. MULTIPLE DEVICES (SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER, AND DRUG COATED BALLOON) WERE USED TO TREAT THE PATIENT. IT WAS NOT REPORTED THAT ANGIOGRAMS WERE TAKEN AFTER USE OF THE TURBO-ELITE; HOWEVER, IMMEDIATELY AFTER USE OF THE TURBO-POWER, ANGIOGRAMS REVEALED A NEW EMBOLIZATION, DESPITE THE EMBOLIC PROTECTION DEVICE BEING IN USE. THE PHYSICIAN REPORTED THE EMBOLIZATION AS A PERIPHERAL VASCULAR INFARCTION, BUT NO FURTHER DETAIL WAS AVAILABLE, AND NO INTERVENTION WAS PERFORMED AFTER THE EMBOLIZATION WAS DISCOVERED. THE PROCEDURE CONTINUED WITH A PLAIN OLD BALLOON ANGIOPLASTY (POBA); ANGIOGRAMS WERE TAKEN IMMEDIATELY AFTER USE OF POBA AS WELL, WITH THE EMBOLIZATION REMAINING. A KANEKA CORPORATION THROMBUSTER ASPIRATION CATHETER WAS USED AFTER POBA TO REMOVE THE EMBOLIZATION, AND THE PROCEDURE WAS COMPLETED, WITH THE OCCLUSION

  Patient problems: Embolism/Embolus

  MAUDE report 17652038 ↗
• MalfunctionJul 27, 2022Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE PATIENT''S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE, THE TURBO-POWER BROKE ON THE WORKING LENGTH OUTSIDE OF THE PATIENT, DUE TO RESISTANCE ENCOUNTERED WHEN THE DEVICE WAS BEING ADVANCED DISTALLY. THE PHYSICIAN BELIEVED THE CAUSE OF THE RESISTANCE WAS DUE TO THE LESION PRESENT WITHIN THE VESSEL. THE TURBO-POWER WAS REMOVED, A 3 MM ANGIO BALLOON WAS USED TO CREATE A PILOT CHANNEL, THEN A NEW TURBO-POWER 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 15115692 ↗
• InjuryJun 14, 2022Chemical Problem; Chemical Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED, FIBROUS LESION IN THE PATIENT'S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. AFTER THE PHYSICIAN HAD SUCCESSFULLY MADE THREE PASSES THROUGH THE LESION, HE ATTEMPTED TO REMOVE THE TURBO-POWER FROM THE OUTER SHEATH BUT IT WAS STUCK. ATTEMPTS WERE MADE TO TAKE THE OUTER SHEATH APART TO REMOVE, BUT THEY WERE UNSUCCESSFUL. THE TURBO-POWER, THE OUTER SHEATH AND THE GUIDE WIRE WERE REMOVED TOGETHER FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE PATIENT WAS TO BE BROUGHT BACK IN TWO DAYS TO BALLOON THE VESSEL. THIS REPORT CAPTURES THE TURBO-POWER WHICH BECAME STUCK AND NECESSITATED REMOVAL AS A SYSTEM, REQUIRING INTERVENTION AT A LATER DATE.

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

  MAUDE report 14686509 ↗
• MalfunctionMay 9, 2022Mechanical Jam; Mechanical Jam

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE PATIENT''S SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS WAS OBTAINED IN THE PATIENT''S RIGHT COMMON FEMORAL ARTERY (CFA) AND PLACED A COOK ANSEL OUTER SHEATH UP AND OVER THE AORTIC BIFURCATION INTO THE LEFT CFA. A WIRE WAS SUCCESSFULLY INSERTED THROUGH THE MID TO DISTAL SFA OCCLUSION AND USED A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. WHEN THE TURBO-POWER ADVANCED OVER THE AORTIC BIFURCATION, RESISTANCE WAS FELT AND THE TURBO-POWER WOULD NOT ADVANCE ANY FURTHER. THE TURBO POWER WAS ATTEMPTED TO BE REMOVED OVER THE WIRE AND OUT OF THE OUTER SHEATH, BUT IT BECAME STUCK AND THE WIRE KINKED. THE TURBO-POWER WAS ABLE TO BE BACKED FAR ENOUGH OVER THE WIRE TO CUT THROUGH THE EXCESS SHEATH THAT WAS OUTSIDE THE SKIN TRACT AND THE WIRE AND THE TURBO-POWER WERE REMOVED TOGETHER. THE REMAINING OUTER SHEATH WAS CLAMPED WITH HEMOSTATS TO REDUCE BLEEDING, THEN ANOTHER 0.035 J WIRE WAS ADVANCED THROUGH THE REMAINING SHEATH TO SAVE ACCESS TO THE RIGHT FEMORAL ARTERY. THE CUT OUTER SHEATH WAS THEN REMOVED OVER THE J WIRE AND A NEW COOK ANSEL SHEATH WAS INSERTED. A NEW SPECTRANETIC

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14340606 ↗