SPRINTER® LEGEND SPL12512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169271760), received between Dec 23, 2020 and Jan 9, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJan 9, 2025Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING THE REMOVAL OF ONE SPRINTER LEGEND DEVICE FOLLOWING INFLATION AT NOMINAL PRESSURE IN A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 60% STENOSIS IN THE DISTAL DIAGONAL BRANCH OF THE ARTERY, A DETACHMENT AT THE TIP OF THE BALLOON CATHETER OCCURRED. DUE TO THE EXTREME CALCIUM, THE BALLOON CATHETER WAS DELIVERED WITH SLIGHT DIFFICULTY. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE AND UPON REMOVAL SHEERED OFF. ATTEMPTS WERE MADE TO SNARE, REWIRE, AND USE A SUCTION DEVICE TO REMOVE THE DETACHED PORTION, BUT THE DISTAL PORTION OF THE CATHETER REMAINED IN THE PATIENT'S DISTAL DIAGONAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE OR EXCESSIVE FORCE WAS NOT ENCOUNTERED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 21109774 ↗
• MalfunctionDec 23, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 70-80% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS 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. IT WAS REPORTED THAT THE BALLOON BURST DURING BALLOON INFLATION. IT WAS STATED THAT THE BALLOON WAS PUNCTURED BY A PIECE OF CALCIUM IN THE VESSEL. AN NC BALLOON WAS THEN USED TO PREP THE LESION SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064120 ↗