SPRINTER® LEGEND SPL12506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169271746), received between Jun 23, 2017 and Apr 22, 2022 — classified as 2 injuries.

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

• InjuryApr 22, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED AND FIBROTIC LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE BALLOON MATERIAL AND BALLOON SHAFT DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. IT WAS STATED THAT THE BALLOON WAS PASSED OVER THE GUIDEWIRE AND PROLONGED ATTEMPTS WERE MADE TO CROSS THE FIBROTIC LESION. THE BALLOON DID NOSE INTO THE LESION WITH THE BALLOON MARKER PROXIMALLY LOCATED IN THE MID-SEGMENT OF THE LESION. THE BALLOON WAS INFLATED ABOUT 15 TO 20 TIMES AT PRESSURES UP TP 20 ATM. HOWEVER, THE BALLOON STILL COULD NOT FULLY PASS THE LESION. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO REMOVE THE BALLOON AND DURING REMOVAL ATTEMPTS THE BALLOON TORE AND COULD NOT BE REMOVED FROM THE LESION. IT WAS ALSO REPORTED THAT THE BALLOON SHAFT SNAPPED AT THE PROXIMAL END OF THE BALLOON, AND WAS REMOVED INTACT. AN ATTEMPT WAS THEN MADE TO PASS A 1.5MM NON-MEDTRONIC BALLOON ACROSS THE LESION IN ORDER TO

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 14185571 ↗
• InjuryJun 23, 2017Burst Container or Vessel; Burst Container or Vessel

  THEY PHYSICIAN WAS ATTEMPTING TO USE ONE SPRINTER LEGEND BALLOON CATHETER TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY DURING PCI PROCEDURE. THE DEVICE WAS INSERTED THROUGH THE GUIDE CATHETER INTO THE LESION. IT WAS REPORTED THAT ON INFLATION, THE BALLOON RUPTURED AND BROKE OFF IN THE LESION. THE PHYSICIAN CARRIED OUT MULTIPLE ATTEMPTS TO REMOVE THE BALLOON FRAGMENT ULTIMATELY RESULTING IN EMBOLIZATION OF THE BALLOON FRAGMENT. THE PHYSICIAN DECIDED TO LEAVE THE FRAGMENT IN PLACE.

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

  MAUDE report 6663251 ↗