SPRINTER® LEGEND SPL15012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994902313), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE SPRINTER LEGEND BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID-PROXIMAL CX. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE BALLOON DETACHED DURING DELIVERY THROUGH THE VESSEL. ANOTHER BALLOON WAS USED TO REMOVE THE DETACHED PORTION FROM THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10711359 ↗