SPRINTER® LEGEND SPL15020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994902467), received between Oct 25, 2018 and Aug 15, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT A BALLOON BURST OR BALLOON LEAK OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548902 ↗
• MalfunctionOct 29, 2018Burst Container or Vessel

  BALLOON PLACED IN LEFT ANTERIOR DESCENDING CORONARY ARTERY. DOCTOR INFLATED BALLOON. BALLOON BURST IN ARTERY. BALLOON MARKER VISUALIZED UNDER FLUOROSCOPY IN SEPTAL PERFORATOR CORONARY ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8013617 ↗
• InjuryOct 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX CORONARY PTCA BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID LAD . THE DEVICE WAS INSPECTED WITH NO ISSUES. (B)(6) PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON WAS INFLATED TO 8ATM AND A BALLOON RUPTURE OCCURRED INSIDE THE PATIENT. THE MID MARKER BAND DISLODGED INTO THE SEPTAL PERFORATOR CORONARY ARTERY. BALLOON DEBRIS AND THE MID MARKER BAND REMAIN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY ROTATIONAL ATHERECTOMY AND STENTING. THE PATIENT WAS DISCHARGED. THE PATIENT IS REPORTED TO BE ALIVE WITH INJURY.

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

  MAUDE report 8004220 ↗