Herculink Elite 1011492-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648077982), received between May 5, 2017 and May 5, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryMay 5, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HERCULINK ELITE STENT WAS INADVERTENTLY MANIPULATED BY AN INEXPERIENCED TECHNICIAN DURING DEVICE PREPARATION. THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ABLE TO REACH THE HEAVILY CALCIFIED RENAL ARTERY, BUT THE STENT DISLODGED WHEN TRYING TO CROSS THE LESION. THE STENT REMAINED ON THE GUIDE WIRE AND WAS ABLE TO BE RETRACTED INTO THE SHEATH AND ALL DEVICES WERE REMOVED AS A UNIT. WHEN THE SDS WAS OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE STENT WAS AT THE ACCESS SITE. A CUTDOWN WAS PERFORMED AT THE ACCESS SITE AND THE STENT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548888 ↗