SPRINTER® LEGEND SPL25012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994902832), received between Jun 27, 2018 and Jan 8, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Inflation Problem; Leak/Splash; Material Deformation; Inflation Problem; Leak/Splash; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION AT 8ATM. IT WAS DETAILED THAT THE BALLOON WOULD NOT INFLATE DURING INFLATION, IT WAS THEN OBSERVED UNDER FLUOROSCOPY THAT THE BALLOON WAS LEAKING. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462247 ↗
• MalfunctionJun 1, 2022Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  ONE SPRINTER LEGEND BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A LESION WITH 90% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED TO 12 ATM FOR 22 SECONDS AND THEN FOR 21 SECONDS.  IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON WAS INFLATED TO 12 ATM, AN ATTEMPT WAS MADE TO COME DOWN AND GO BACK UP TO 12 ATM AND THEN ATTEMPTED TO COME DOWN AGAIN. THE INFLATION DEVICE WAS CHANGED BUT THAT DID NOT WORK SO THE BALLOON WAS THEN PULLED BACK INTO THE GUIDE AND REMOVED FROM THE PATIENT. A RESOLUTE ONYX STENT WAS DEPLOYED IN THE DISTAL RCA DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14562535 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE SPRINTER LEGEND RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A 75% CALCIFIED, NON TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. IT WAS DIFFICULT TO REMOVE THE PROTECTIVE SHEATH, THERE WAS NO DIFFICULTY REMOVING THE PACKAGING STYLETTE. 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 TRAVERSE GUIDEWIRE WAS 300CM. THE GUIDEWIRE WAS USED SUCCESSFULLY WITH OTHER DEVICES PRIOR TO THE DIFFICULTY OCCURRING. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE WIRE ENTRY PORT. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE DEVICE ONTO THE GUIDEWIRE. IT WAS REPORTED THAT THERE WAS POOR GUIDE WIRE MOVEMENT DURING THE PROCEDURE. IT WAS ATTEMPTED TO RE-POSITION THE WIRE AND BRING IT BACK TO THE BALLOON. IT WAS STATED THAT THE TRAVERSE WIRE GOT STUCK IN THE BALLOON. THE WIRE AND THE BALLOON WERE THEN REMOVED AS ONE UNIT. IT WAS INDICATED THAT THE SPRINTER LEGEND DEVICE LOOKED DAMAGED DUE TO THE ATTEMPTS TO REMOVE THE WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11818399 ↗
• InjuryMay 4, 2021Deflation Problem; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE MOVED IN THE LESION WHILE INFLATED. THE DEVICE WAS PULLED OUT. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY. THE EVENT RESULTED IN STELEVATION AND THE PATIENT IS IN HOSPITAL ON ECMO.

  Patient problems: Non specific EKG/ECG Changes; Unspecified Tissue Injury

  MAUDE report 11768456 ↗
• MalfunctionJun 27, 2018Deflation Problem; Deflation Problem

  ONE SPRINTER LEGEND PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO PRE-DILATE A LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR STYLETTE FROM THE DEVICE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND WAS UNABLE TO DEFLATE AT THE LESION SITE AFTER THE FIRST INFLATION. THE DEVICE HAD NOT BEEN MOVED OR RE-POSITIONED PRIOR TO DEFLATION DIFFICULTIES. A 50/50 CONTRAST TO SALINE SOLUTION WAS USED. THE ENTIRE DELIVERY SYSTEM WAS THEN PULLED OUT, WITH THE WIRE, FROM THE VESSEL. IT WAS INFORMED THAT THE LARGE ARTERY ALLOWED FOR THE SUCCESSFUL REMOVAL OF THE DEVICE WITH NO ISSUES. A NON-MEDTRONIC BALLOON CATHETER WAS THEN USED TO PRE-DILATE AND STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION SITE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641335 ↗