SPRINTER® LEGEND SPL30015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994901583), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 injury.

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.

• InjuryMar 6, 2018Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  A SPRINTER LEGEND RX BALLOON CATHETER WAS INTENDED TO BE USED TO TREAT A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL RCA LESION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING BALLOON INFLATION TO 21ATM. THE ISSUE OCCURRED ON THE FIRST INFLATION AND THERE WAS A SUDDEN DROP IN PRESSURE. THE DEVICE HAD NOT BEEN MOVED/RE-POSITIONED IN THE LESION PRIOR TO THE BURST. IT WAS REPORTED THAT THERE WAS A BALLOON FRAGMENT THAT WAS UNABLE TO BE REMOVED FROM THE PATIENT. A RESOLUTE ONYX DRUG ELUTING STENT WAS USED TO TRAP THE BALLOON FRAGMENT. IT WAS ALSO REPORTED THAT A MARKER BAND WAS VISUALIZED IN THE ARTERY AFTER THE BALLOON BURST. THE PHYSICIAN BELIEVES THAT THE MARKER BAND VISUALISED IN THE SMALL DISTAL BRANCH OF THE RCA IS FROM THE BURST SPRINTER LEGEND BALLOON. THE PHYSICIAN COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED AND THE PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism; Patient Problem/Medical Problem

  MAUDE report 7316664 ↗