Herculink Elite 1011502-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648078293), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• InjuryJun 13, 2018Migration or Expulsion of Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE CELIAC ARTERY. THE 6.5 X 18 MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM) TO DEPLOY THE STENT. ONCE THE BALLOON WAS DEFLATED, IT WAS NOTED THAT THE DEPLOYED STENT HAD MOVED DISTALLY INTO THE AORTA. THE SDS BALLOON WAS ADVANCED INTO THE STENT AND INFLATED SLIGHTLY, THUS PULLING THE STENT BACK TO THE SHEATH. A VASCULAR SURGEON WAS THEN CALLED AND A CUT DOWN WAS PERFORMED, REMOVING THE STENT FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599359 ↗