Herculink Elite 1011502-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648078286), received between Mar 19, 2020 and Mar 19, 2020 — classified as 1 malfunction.

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.

• MalfunctionMar 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED RENAL ARTERY. THE HERCULINK ELITE STENT SYSTEM WAS ADVANCED THROUGH THE UNSPECIFIED GUIDE CATHETER AND IT WAS NOTED THAT THE STENT DISLODGED, REMAINING IN THE GUIDE CATHETER. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT. AS THE STENT REMAINED IN THE GUIDE CATHETER, THE DEVICES WERE REMOVED AS A SINGLE UNIT, WITHOUT DIFFICULTY, AND THE STENT REMAINED IN THE GUIDE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857937 ↗