SPRINTER® LEGEND SPL25020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994902566), received between Jul 24, 2018 and Oct 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND CORONARY BALLOON CATHETER TO TREAT A LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED THROUGHOUT MULTIPLE TIMES WITH A 1MM NON-MEDTRONIC BALLOON WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DIFFICULTIES WERE NOTED DURING INFLATION OF THE DEVICE, AS THE BALLOON DID NOT INFLATE EVENLY. AN INFLATION PRESSURE OF 10 ATM WAS APPLIED, AND DEFLATION DIFFICULTIES OCCURRED AFTER THE FIRST INFLATION. THE BALLOON FAILED TO DEFLATE AND REMAINED WEDGED WITHIN THE ARTERY. ATTEMPTS WERE MADE TO TRY AND DEFLATE AND REINFLATE THE BALLOON, BUT THIS DID NOT CHANGE ANYTHING. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE BALLOON WAS INFLATED BEYOND THE RATED BURST PRESSURE TO TRY AND I

  Patient problems: Insufficient Information

  MAUDE report 20425681 ↗
• MalfunctionJul 24, 2018Deflation Problem; Tear, Rip or Hole in Device Packaging; Deflation Problem

  A SPRINTER LEGEND BALLOON CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT IS REPORTED THAT THE BALLOON FAILED TO DEFLATE AT THE LESION SITE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713295 ↗