Herculink Elite 1011502-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648078279), received between Oct 8, 2018 and Oct 8, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED LESION IN THE RENAL ARTERY. DURING A PERCUTANEOUS INTERVENTION, THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY. DURING SDS RETRACTION, RESISTANCE WAS MET RETRACTING THE DEVICE INTO THE GUIDE CATHETER. DURING RETRACTION, THE HERCULINK ELITE STENT DISLODGED INTO THE ILIAC ARTERY. A WIRE WAS ATTEMPTED TO RETRIEVE THE DISLODGED HERCULINK ELITE STENT, HOWEVER, THE STENT THEN TRAVELED INTO THE PROFUNDA ARTERY. IT WAS DECIDED TO LEAVE THE STENT FREE FLOATING IN THE PROFUNDA AND NO ADDITIONAL TREATMENT WAS PROVIDED. ANOTHER HERCULINK ELITE STENT WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7945252 ↗