Sprinter Legend™ SPL12515WLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169854963), received between Aug 22, 2018 and Feb 14, 2020 — classified as 1 death, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Burst Container or Vessel; Inflation Problem; Material Deformation; Burst Container or Vessel; Inflation Problem; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND OVER THE WIRE (OTW) PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE DISTAL LEFT SFA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST/RUPTURED DURING INITIAL BALLOON INFLATION AT 6 ATMS. IT WAS STATED THAT THE LESION WAS INITIALLY CROSSED WITH A NON MEDTRONIC CTO 25G WIRE WITH SUPPORT CATHETER. AN ATTEMPT TO TREAT THE LESION WITH A NON MEDTRONIC BALLOON WAS UNSUCCESSFUL. THE SPRINTER LEGEND OTW PTCA BALLOON CATHETER WAS THEN ADVANCED AND CROSSED THE LESION. INFLATION WAS INITIATED WITH 60% HEP SAL / 40% OMNIPAQUE. UPON SLOW INFLATION, UNDER FLUOROSCOPY, THE BALLOON VISUALLY RUPTURED AT 6 ATM. THE DEVICE WAS REMOVED INTACT WITHOUT ISSUES. THE PROCEDURE WAS COMPLETED USING A MEDTRONIC EUPHORA PTCA BALLOON CATHETER AND NON MEDTRONIC DEVICES. THE PATIENT WAS REPORTED TO BE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710458 ↗
• DeathAug 22, 2018Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  A SPRINTER LEGEND OTW BALLOON DILATATION CATHETER WAS USED IN A MIDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LAD. LESION HAD 90% STENOSIS. THE LESION WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO THE SPRINTER LEGEND OTW PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/ TRAY. THE BALLOON CATHETER WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE BALLOON CATHETER DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE BALLOON HOWEVER EXCESSIVE FORCE WAS NOT APPLIED. DURING FIRST BALLOON INFLATION AT 10 ATMS THE BALLOON BURST. REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON AND MARKER DETACHED FROM THE CATHETER SHAFT AND WERE LEFT IN THE LAD. THE DETACHED BALLOON MARKER WAS NOT REMOVED FROM THE PATIENT. PATIENT UNDERWENT CABG THE NEXT DAY IN A DIFFERENT HOSPITAL BUT PASSED AWAY AFTER THE PROCEDURE. MESENTERIC ISCHEMIA IS REPORTED TO BE THE CAUSE OF DEATH. IT IS REPORTED THAT THE SPRINTER LEGEND DEVICE WAS INDIRECTLY THE CAUSE OF DEATH DUE TO BYPASS SURGERY WITH BALLOON MATERIAL IN THE CORONARY ARTERY.

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

  MAUDE report 7804264 ↗