Herculink Elite 1011492-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648077975), received between Dec 21, 2017 and Jul 23, 2019 — 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.

• MalfunctionJul 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE 5.0X12MM HERCULINK ELITE STENT SYSTEM WAS REMOVED FROM THE DISPENSER COIL AND IT WAS NOTED THAT THE TIP HAD SEPARATED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED HERCULINK STENT SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8819477 ↗
• InjuryDec 21, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 5.0X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE RENAL ARTERY THROUGH THE FEMORAL ARTERY ACCESS SITE WHEN THE STENT DISLODGED FROM THE SDS. THE DISLODGED STENT WAS SUCCESSFULLY RETRIEVED VIA SNARE, BUT THE FEMORAL ARTERY BECAME PERFORATED DURING REMOVAL. A COVERED STENT WAS IMPLANTED TO TREAT THE PERFORATION. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Perforation

  MAUDE report 7140422 ↗