SPRINTER® LEGEND SPL12510XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169271753), received between Nov 6, 2017 and Nov 13, 2025 — classified as 3 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SPRINTER LEGEND RX BALLOON, THE BALLOON DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, SEVERELY CALCIFIED WITH 100% CHRONIC TOTAL OCCLUSION (CTO) INTHE DISTAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE SPRINTER LEGEND BALLOON WAS ADVANCED TO THE LESION SITE USING A TELESCOPE GUIDE EXTENSION CATHETER (GEC). THERE WERE MULTIPLE INFLATIONS TO 12ATM PERFORMED. UPON RETRIEVAL, THE SPRINTER LEGEND BALLOON SHEARED AT THE MARKER, RESULTING IN A PORTION OF THE MID MARKER AND SOME BALLOON MATERIAL REMAINING IN THE DISTAL END OF THE OBTUSE MARGINAL BRANCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23542349 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SPRINTER LEGEND BALLOON CATHETER WAS USED TO PRE-DILATE A NON-TORTUOUS, NON-CALCIFIED LESION IN THE MID OM. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. (B)(6) PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED ST ENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT AS THE PHYSICIAN INFLATED THE BALLOON THEY NOTICED AN ANEURYSM HAD DEVELOPED PROXIMAL TO THE LESION. IT IS UNKNOWN IF THE BALLOON WAS THE CAUSE. THE PATIENT IS REPORTED AS BEING ALIVE WITHOUT INJURY.

  Patient problems: Aneurysm

  MAUDE report 7513478 ↗
• InjuryMar 14, 2018Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A SPRINTER LEGEND RX BALLOON TO TREAT A CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL LEFT CIRCUMFLEX WITH 90 % LESION STENOSIS. NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED. A ROTOBLATOR WAS USED IN THE DISTAL LEFT MAIN INTO LAD TO TREAT THE CALCIFIED LESION FOLLOWED BY A 2.0 MM AND A 3.0 MM NON-MEDTRONIC BALLOONS. THE NON-MEDTRONIC BALLOONS WERE USED PRIOR TO USING THE SPRINTER LEGEND 1.25 MM, BUT BOTH NON-MEDTRONIC BALLOONS DID NOT CROSS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A BALLOON BURST/LEAK OCCURRED. THE BALLOON BURST IN THE PROXIMAL LEFT CIRCUMFLEX AT 18 ATM. IT WAS REPORTED THAT THE MARKER BAND DISLODGED AFTER DEPLOYMENT IN THE PROXIMAL LEFT CIRCUMFLEX. IT WAS OBSERVED THAT THE MARKER BAND MIGRATED FROM THE PROXIMAL LEFT CIRCUMFLEX TO A BRANCH OF THE LEFT CIRCUMFLEX. AN ATTEMPT WAS MADE TO RECOVER THE DISLODGED MARKER BAND. A NON-MEDTRONIC CATHETER WAS ADVANCED OVER THE TIP OF THE BALLOON CATHETE R, IN THE LEFT CX, THEN THE NON-MEDTRONIC CATHET

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

  MAUDE report 7337095 ↗
• MalfunctionNov 6, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE A SPRINTER LEGEND BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THERE WERE NO ABNORMALITIES IN ANATOMY. IT IS REPORTED THAT A BALLOON BURST OR LEAK OCCURRED ON THE FIRST INFLATION AFTER 12 ATM OF PRESSURE HAD BEEN APPLIED. THE BALLOON BURST WHILE BEING EXPANDED IN THE PATIENT WITH HEAVY CALCIUM. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE BURST. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURERS PRODUCT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7002961 ↗