SPRINTER® LEGEND SPL20015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994902122), received between Jan 16, 2018 and Jan 4, 2019 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJan 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE DIAGONAL BRANCH. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED OR FRACTURED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217231 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND ONE SPRINTER LEGEND RX BALLOON CATHETER WAS ALSO USED TO TREAT THE RCA. DURING THE PROCEDURE PERFORATION OF THE PROXIMAL RCA OCCURRED BY AN UNKNOWN DEVICE. THE INVESTIGATOR REPORTED THAT THE EVENT IS CAUSALLY RELATED TO THE DEVICE BUT NOT RELATED TO THE ANTI PLATELET MEDICATION. THE PATIENT RECOVERED. THE CEC ADJUDICATED THE EVENT TERM AS "NEW CORONARY ARTERY PERFORATION (RCA).

  Patient problems: Perforation

  MAUDE report 7532541 ↗
• MalfunctionJan 16, 2018Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE A SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION LOCATED AT THE PROXIMAL FIRST OBTUSE MARGINAL ARTERY EXHIBITING 80-90% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATM. IT WAS DESCRIBED THAT THE BALLOON WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN USED ANOTHER BALLOON TO DILATE THE LESION WITH NO ISSUES. PATIENT STATUS POST PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7193533 ↗