Turbo-Elite Laser Atherectomy Catheter 414-159Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132024727), received between Aug 17, 2021 and Oct 11, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (3 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 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 · Recall details · FDA record ↗

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.

• MalfunctionOct 11, 2023Wrong Label; Wrong Label

  DURING PREPARATION FOR USE, IT WAS DISCOVERED THAT UPON OPENING A BOX LABELED WITH A SPECTRANETICS 1.4 TURBO-ELITE LASER ATHERECTOMY CATHETER, THE BOX CONTAINED A 2.0 TURBO-ELITE. THE DEVICE WAS NOT USED IN THE PATIENT, AND THERE WAS NO REPORTED INJURY. THIS REPORT CAPTURES THE LABELING DISCREPANCY THAT A LARGER SIZE DEVICE WAS CONTAINED INSIDE THE BOX, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913496 ↗
• MalfunctionOct 11, 2023Wrong Label; Wrong Label

  DURING PREPARATION FOR USE, IT WAS DISCOVERED THAT UPON OPENING A BOX LABELED WITH A SPECTRANETICS 1.4 TURBO-ELITE LASER ATHERECTOMY CATHETER, THE BOX CONTAINED A 2.0 TURBO-ELITE. THE DEVICE WAS NOT USED IN THE PATIENT, AND THERE WAS NO REPORTED INJURY. THIS REPORT CAPTURES THE LABELING DISCREPANCY THAT A LARGER SIZE DEVICE WAS CONTAINED INSIDE THE BOX, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913492 ↗
• MalfunctionOct 11, 2023Wrong Label; Wrong Label

  DURING PREPARATION FOR USE, IT WAS DISCOVERED THAT UPON OPENING A BOX LABELED WITH A SPECTRANETICS 1.4 TURBO-ELITE LASER ATHERECTOMY CATHETER, THE BOX CONTAINED A 2.0 TURBO-ELITE. THE DEVICE WAS NOT USED IN THE PATIENT, AND THERE WAS NO REPORTED INJURY. THIS REPORT CAPTURES THE LABELING DISCREPANCY THAT A LARGER SIZE DEVICE WAS CONTAINED INSIDE THE BOX, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913490 ↗
• MalfunctionJul 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED LESION IN THE PATIENT'S MID POPLITEAL ARTERY. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER THE PROCEDURE WAS COMPLETED SUCCESSFULLY, IT WAS NOTICED THAT THE TURBO ELITE WAS SLICED OR COMING APART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15108431 ↗
• MalfunctionJun 14, 2022Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED, PLAQUE LESION IN THE PATIENT'S DISTAL POSTERIOR TIBIAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. AFTER THE TREATMENT HAD BEEN COMPLETED, THE TURBO ELITE WAS REMOVED FROM THE OUTER SHEATH AND THE PHYSICIAN NOTICED THE FIBERS OF THE TURBO ELITE WERE EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14688935 ↗
• MalfunctionMay 11, 2022Degraded; Degraded

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE PATIENT'S DISTAL ANTERIOR TIBIAL (AT) VESSEL. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE IN THE PROCEDURE, IT WAS REPORTED THE TIP OF THE CATHETER AND THE SHEATH APPEARED BURNED. A NEW TURBO ELITE OF THE SAME MODEL 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: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 14366167 ↗
• MalfunctionAug 17, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED LESION IN THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. AFTER THE PHYSICIAN USED THE TURBO ELITE DEVICE IN THE PATIENT AND WAS REMOVING THE DEVICE, HE NOTICED THE "OUTER SHEATH WAS TORN" AND FIBERS WERE VISIBLE. IT WAS REPORTED THAT THERE WAS DIFFICULTY GETTING THE TURBO ELITE DEVICE THROUGH THE SHEATH AND BELIEVED THAT MAY HAVE BEEN THE REASON THE DEVICE WAS DAMAGED. A NEW SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO FINISH THE PROCEDURE, AND THERE WAS NO REPORTED PATIENT HARM. THIS EVENT IS BEING SUBMITTED TO CAPTURE THE TURBO ELITE WHICH WAS FOUND DAMAGED DURING USE AND RESULTED IN UNINTENDED RADIATION EXPOSURE WITH POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12333209 ↗