Turbo-Elite Laser Atherectomy Catheter 423-135-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132024796), received between May 15, 2019 and Jun 23, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2020Break; Break

  IN THE INITIAL MDR SUBMITTED FOR THIS EVENT, IT WAS REPORTED THAT "THE PHYSICIAN REPORTED HAVING TROUBLE FEEDING THE GUIDEWIRE THROUGH THE GUIDE PORT OF THE DEVICE. THE GUIDE PORT EVENTUALLY BROKE CAUSING DAMAGE TO THE CATHETER." UPON FURTHER DISCUSSION ON 25 JUNE 2020 WITH THE PHILIPS REPRESENTATIVE WHO WAS PRESENT AT THE CASE, IT WAS DISCOVERED THAT THE DAMAGE TO THE DEVICE WAS NOT CAUSED BY A GUIDEWIRE. REPORTEDLY, ALTHOUGH THE BREACH TO THE OUTER JACKET OF THE DEVICE MAY HAVE BEEN AT THE AREA OF THE LASER CATHETER WHERE THE GUIDE WIRE IS INSERTED (CANNOT CONFIRM BECAUSE THE DEVICE IS NOT BEING RETURNED), AN OUTER SHEATH (MANUFACTURER UNKNOWN) WAS BEING USED IN A CONTRALATERAL APPROACH TO TREAT THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO GET THROUGH THE FIRST PORTION OF THE OUTER SHEATH BUT AT THE BIFURCATE, IT BECAME DIFFICULT TO ADVANCE THE DEVICE. IT WAS AT THAT TIME THAT THE DEVICE WAS DISCOVERED TO BE DAMAGED.

  Patient problems: Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 10183976 ↗
• InjuryMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A VASCULAR INTERVENTION TO TREAT PERIPHERAL ARTERY DISEASE IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY, A SPECTRANETICS TURBO ELITE DEVICE WAS IN USE. DURING THE PROCEDURE, THE DEVICE'S RADIOPEQUE MARKER BAND DISCONNECTED WHILE DEVICE WAS BEING USED IN THE PATIENT. RING CAME APART INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE MARKER BAND USING A FILTER WIRE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612807 ↗