Herculink Elite 1011504-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648078354), received between Apr 30, 2018 and Jun 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 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.

• MalfunctionJun 19, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS RIGHT RENAL ARTERY. A .014 SPARTACORE GUIDE WIRE WAS USED WITH THE INCOMPATIBLE 8 X 19MM ON 80CM OMNILINK ELITE BALLOON-EXPANDABLE STENT SYSTEM (BES) DUE TO VESSEL SIZING. THE BES EXPERIENCED SUPPORT AND TURNING ISSUES, BUT DID NOT FACE RESISTANCE. A NON-ABBOTT SUPPORT CATHETER WAS USED TO EXCHANGE GUIDE WIRES; HOWEVER, THE .014 GUIDE WIRE WAS NOT REPLACED WITH THE RECOMMENDED .035 GUIDE WIRE DUE TO POOR POSITIONING OF THE SUPPORT CATHETER AND FEAR OF LOSING WIRE ACCESS IF ATTEMPTED. THE OMNILINK BES WAS REMOVED WITHOUT ISSUES. THE SAME SPARTACORE GUIDE WIRE HAD NO ISSUES AND WAS USED WITH THE 7 X 18MM ON 80CM HERCULINK BES, WITH NO ISSUES. DURING DEPLOYMENT, THE BALLOON WAS INTENTIONALLY INFLATED SLOWLY, AND THE STENT MOVED 4MM DISTAL FROM WHERE INTENDED, PARTIALLY OUTSIDE OF THE TARGET LESION. A 7 X 15MM HERCULINK BES WAS DEPLOYED PROXIMALLY TO THE FIRST HERCULINK STENT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714253 ↗
• MalfunctionApr 30, 2018Difficult To Position; Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL MESENTERIC ARTERY. THE 7.0 X 18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ONTO THE GUIDE WIRE; HOWEVER, WHILE ATTEMPTING TO ADVANCE INTO THE 6F SHEATH, RESISTANCE WAS NOTED WITH THE SHEATH PRIOR TO ENTERING THE ANATOMY. THE SDS WAS REMOVED WITHOUT ISSUE AND IT WAS NOTED THAT A STENT STRUT WAS FLARED UP. THE SDS WAS NO LONGER USED AND REPLACED. A NEW HERCULINK ELITE SDS WAS USED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS MOVED ON THE BALLOON. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS MOVED ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473688 ↗