Turbo-Power Laser Atherectomy Catheter 423-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132026776), received between Aug 31, 2022 and Nov 9, 2022 — classified as 2 injuries.

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

• InjuryNov 9, 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 BEGAN TO TREAT AN IN-STENT RESTENOSIS (ISR) IN THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL REGION. THE LESION TO BE TREATED WAS 400 MM IN LENGTH, WITH HEAVY THROMBUS PRESENT WITHIN THE STENTS. IT WAS PREDICTED THAT TREATMENT WOULD RESULT IN CLOTS AND POTENTIAL EMBOLISM; THEREFORE, A FILTER WAS PLACED PRE-PROCEDURE, DISTAL TO THE LESION. THE PHYSICIAN CHOSE TO TREAT THE PATIENT WITH A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER. DURING USE, AND AS EXPECTED, PORTIONS OF THE THROMBUS WERE OBSERVED. THE FILTER DID NOT CATCH ALL THE THROMBUS, RESULTING IN A PERIPHERAL EMBOLISM. THE THROMBUS THAT WAS NOT CAPTURED BY THE FILTER WAS REMOVED SUCCESSFULLY USING A MECHANICAL THROMBECTOMY CATHETER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO-POWER IN USE WITHIN THE LESION WHEN THE PERIPHERAL EMBOLISM OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Thromboembolism

  MAUDE report 15765107 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2022 TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT'S LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A STENT HAD BEEN PLACED IN THIS AREA PRIOR TO THE PROCEDURE, AND THE PATIENT WAS EXPERIENCING A WOUND AND NUMBNESS IN THE LEFT LOWER EXTREMITY. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT, FOLLOWED BY BALLOON THERAPY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FOLLOWING THE INITIAL PROCEDURE, THE PATIENT WAS TREATED WITH ANTIMICROBIALS AND ANTICOAGULANTS. HOWEVER, SOME NUMBNESS REMAINED AFTER THE PROCEDURE, SO THE PATIENT WAS CHECKED DAILY BY DOPPLER ULTRASONOGRAPHY AND PALPATION. OVER THE NEXT FEW DAYS, TESTING SHOWED A DECREASED LEFT ANKLE/BRACHIAL INDEX (ABI) WHICH CAN INDICATE WORSENING PERIPHERAL ARTERY DISEASE (PAD). ON (B)(6) 2022, AN ECHO WAS PERFORMED AND THE FOLLOWING DAY, THE PHYSICIAN DIAGNOSED AN IN-STENT RESTENOSIS (ISR) IN THE SAME REGION TREATED INITIALLY. ON(B)(6) 2022, A PROCEDURE COMMENCED TO TREAT THE ISR, USING A TURBO-POWER, A PLAIN OLD BALLOON ANGIOPLASTY (POBA), AND A STENT GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Restenosis

  MAUDE report 15332257 ↗