Herculink Elite 1011496-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648078118), received between Jul 6, 2020 and Sep 21, 2023 — classified as 1 injury, 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 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.

• MalfunctionSep 21, 2023Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CELIAC ARTERY. THE 5.5X18MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND CROSSED THE LESION. MARKERS WERE ON THE CATHETER AND NOTHING WAS OUT OF THE ORDINARY. THE BALLOON WAS INFLATED AND DEFLATED WITH THE STENT ASSUMED TO HAVE BEEN DEPLOYED. HOWEVER, THE STENT COULD NOT BE CONFIRMED VIA ANGIOGRAM. THE STENT COULD NOT BE FOUND ANYWHERE IN THE ANATOMY OR IN THE SHEATH. THE PREP TABLE/BACK TABLE, THE FLOOR, THE PACKAGING AND DISPENSER HOOP WERE SEARCHED AND THE STENT COULD NOT BE LOCATED ANYWHERE. AN OMNILINK STENT WAS IMPLANTED WITHOUT ISSUES TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790045 ↗
• InjuryJul 6, 2020Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RENAL ARTERY. THE 5.5 X 18 MM HERCULINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED. HOWEVER, THE STENT DELIVERY SYSTEM HAD DIFFICULTY ADVANCING INTO THE VESSEL, DUE TO THE ANATOMY, AND AN ATTEMPT WAS MADE TO REMOVE. RESISTANCE WAS NOTED AND THE DEVICE WAS UNABLE TO BE REMOVED. A GUIDE CATHETER WAS ADVANCED OVER THE STENT DELIVERY SYSTEM AND THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED. IT WAS NOTED THAT A STENT STRUT WAS FLARED AND IT WAS SUSPECTED THAT THE FLARED STENT STRUT WAS CATCHING ON THE VESSEL WALL. NO TISSUE DAMAGE WAS NOTED DUE TO THE DIFFICULTY REMOVING THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE CONTINUED WITH IMPLANTATION OF A NON-ABBOTT CORONARY STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237829 ↗