SPRINTER® LEGEND SPL20020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994902092), received between Jul 24, 2017 and Jul 24, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN INTENDED TO USE A SPRINTER LEGEND BALLOON CATHETER TO TREAT A LESION LOCATED IN THE MID OBTUSE MARGINAL (OM) WHICH WAS REPORTED TO BE MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 90% STENOSIS. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE AND DEFLATION DIFFICULTIES WERE EXPERIENCED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO PULL BALLOON BACK AND REMOVE AS PROXIMAL ARTERY WAS LARGER THAN THE BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED DURING DELIVERY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6735715 ↗