SPRINTER® LEGEND SPL15015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994902498), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 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.

• MalfunctionSep 20, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS INTENDED TO USE ONE SPRINTER LEGEND DEVICE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING BALLOON INFLATION AT 10 ATM. ONE INFLATION HAD BEEN APPLIED PRIOR TO THE ISSUE BEING IDENTIFIED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES CALCIUM IN THE LESION CAUSED A TEAR IN THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495117 ↗