Scoreflex NC Scoring PTCA Catheter 617-104-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06934955936258), received between May 15, 2024 and May 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  MULTIPLE NON-CSI/NON-ABBOTT BALLOONS WERE ATTEMPTED TO BE USED IN A SUPER TIGHT PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION, HOWEVER, THE BALLOONS RUPTURED. A SCOREFLEX BALLOON WAS ATTEMPTED TO BE USED IN THE LAD WHEN IT BACKED THE GUIDE UP AND THE WIRE LOOP WAS BEHIND THE SHORT RAPID EXCHANGE CATHETER. THE PHYSICIAN PROCEEDED TO PULL THE BALLOON WITH THE LOOP AND THE BALLOON CAME OFF OF THE WIRE. THE ENTIRE WIRE AND TELEFLEX GUIDELINER WERE PULLED OUT OF THE PATIENT. IT APPEARED THAT THE RAPID EXCHANGE CATHETER MAY HAVE SPLIT, BUT THIS WAS UNABLE TO BE CONFIRMED. THE GUIDELINER WAS FLUSHED AND THE PHYSICIAN RE-WIRED WITH A NEW WIRE TO COMPLETE THE PROCEDURE. BACKGROUND: A SUPER TIGHT PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. IT WAS REPORTED AS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318156 ↗