SPRINTER® LEGEND SPL25015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994902597), received between Jul 4, 2018 and Mar 7, 2024 — classified as 1 injury, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX CORONARY BALLOON CATHETER TO TREAT A LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BROKE AND PERFORATED THE LM ARTERY. THE BALLOON'S INITIAL INFLATION RESULTED IN THE PERFORATION OF THE LM ARTERY. IT WAS STATED THAT PART OF THE BALLOON REMAINS IN THE BODY. A STENT WAS PLACED AND PINNED UP THE PIECE OF BALLOON LEFT IN THE CORONARY ARTERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18855164 ↗
• MalfunctionAug 19, 2020Activation, Positioning or Separation Problem

  ELDERLY FEMALE WITH HISTORY OF CHEST PAIN. PRESENTED WITH BILATERAL ARM PAIN AS WELL AS JAW PAIN. WENT TO CATH LAB AND WHILE TESTING THE DEVICE, THE METAL STYLET WOULD NOT LEAVE THAT BALLOON AS USUAL.

  Patient problems: Pain

  MAUDE report 10424799 ↗
• MalfunctionMar 2, 2020Deflation Problem; Deflation Problem

  DURING A PROCEDURE, ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER WAS USED TO TREAT A LESION. IT WAS REPORTED THAT THERE WAS INFLATION DIFFICULTIES DURING BALLOON INFLATION. IT WAS ALSO REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9773359 ↗
• MalfunctionJan 30, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SPRINTER LEGEND RX PTCA BALLOON RUPTURED WHILE INSIDE THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646604 ↗
• MalfunctionDec 18, 2019Fracture

  AN ELDERLY MALE PATIENT PRESENTS WITH A HISTORY SIGNIFICANT FOR TYPE 1 DIABETES, HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE STATUS POST CORONARY ARTERY BYPASS GRAFTING (CABG), GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND ACUTE RESPIRATORY FAILURE. WHILE PERFORMING A HEART CATHETERIZATION, SYNERGY STENT DEPLOYED ANGIOGRAMS DONE. STENT APPEARED TO HAVE FRACTURE. INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE DONE TO VERIFY. SECOND STENT DEPLOYED OVER FRACTURED STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488668 ↗
• MalfunctionJul 4, 2018Deflation Problem; Deflation Problem

  THE PATIENT PRESENTED WITH ACS, CRUSHING CHEST PAIN AND ST ELEVATION. ONE SPRINTER LEGEND PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH MILD TORTUOSITY AND CALCIFICATION AND 95% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO PATIENT'S ANATOMY. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO RESISTANCE WAS NOTED WHILE ADVANCING THE BALLOON. THE DEVICE WAS NOT MOVED OR REPOSITIONED IN THE LESION. THERE WAS NO INFLATION DIFFICULTY. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AT THE LESION SITE, AFTER FIRST INFLATION. AN ATTEMPT WAS MADE TO PERFORATE THE BALLOON WITH A STIFF WIRE. A GUIDELINER WAS THEN USED TO PARTIALLY PULL THE BALLOON BACK INTO THE GUIDELINER AND ALL WAS REMOVED. THE PATIENT EXPERIENCED SOME CHEST DISCOMFORT DURING THE EVENT BUT IT SUBSIDED ONCE THE BALLOON WAS REMOVED. THE WHOLE EVENT LASTED APPROX. 10 MINUTES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Chest Pain; Patient Problem/Medical Problem

  MAUDE report 7661850 ↗