SPRINTER® LEGEND SPL20012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994902153), received between May 23, 2018 and Nov 8, 2021 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND BALLOON CATHETER TO TREAT A LESION IN THE RCA. THERE WAS NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP AND THE PACKAGING AND PROTECTIVE SHEATH AND STYLETTE LOOKED NORMAL. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS INFLATED TO 14 ATMS. THE INDEFLATOR SHOWED 14 ATM BUT SLOWLY LOST PRESSURE. THERE WAS NO CONTRAST NOTED IN THE VESSEL. THE BALLOON WAS REMOVED FROM THE PATIENT AND A SYRINGE OF SALINE WAS ATTACHED AND HAND PUSHED. A PINPOINT STEAM OF SALINE WAS NOTED TO COME OUT OF THE BALLOON. THE LEAK WAS LOCATED NEAR THE SHAFT OF THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770968 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  DURING A PROCEDURE A SPRINTER LEGEND RX PTCA BALLOON CATHETER WAS INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT THE LUER OF THE DEVICE CRACKED DURING PREPARATION OF THE DEVICE IN VITRO. THE PHYSICIAN STATED THAT WHEN THE INFLATION DEVICE WAS ATTACHED TO THE BALLOON THE ATTACHMENT WAS UNEVEN. IT WAS INDICATED THAT THE LUER CRACKED UPON BALLOON INFLATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883438 ↗
• MalfunctionJul 12, 2019Burst Container or Vessel; Burst Container or Vessel

  A SPRINTER LEGEND RX PTCA BALLOON CATHETER WAS USED TO TREAT A MODERATELY TORTUOSITY AND CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE PROXIMAL RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THERE WAS CALCIUM PRESENT PROXIMAL TO THE TARGET LESION THAT THE BALLOON GOT HUNG UP ON. THE BALLOON HAD TO BE MANIPULATED TO PASS THE CALCIFIED SEGMENT. IT WAS REPORTED THAT THE BALLOON NEVER INFLATED AND RUPTURED IMMEDIATELY. CONTRAST WAS VISIBLE DISTAL TO THE DISTAL MARKERBAND. THE PROCEDURE WAS COMPLETED USING ANOTHER 2.0X12 MM SPRINTER BALLOON. THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783942 ↗
• InjuryMay 23, 2018Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY LESION EXHIBITING 99% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLETTE FROM THE DEVICE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE LESION WAS PREPPED WITH ROTABLATION. AN ATTEMPT WAS MADE TO ADVANCE AND INFLATE THE SPRINTER LEGEND DEVICE. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT ON THE FIRST INFLATION/DEFLATION THE BALLOON WAS SLOW TO DEFLATE. CONTRAST WAS PERCEIVED TO BE IN THE BALLOON. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. ON THE SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE, WITH THE INDEFLATOR AND AN EMPTY

  Patient problems: Heart Failure; Myocardial Infarction; Occlusion; Patient Problem/Medical Problem; ST Segment Elevation; Vascular Dissection

  MAUDE report 7536697 ↗