Herculink Elite 1011490-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648077913), received between Oct 24, 2017 and Apr 1, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RENAL ARTERY. THE 4.50X12MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION HOWEVER STENT DISLODGED FROM THE BALLOON. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT. THE PROCEDURE COMPLETED USING ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756626 ↗
• MalfunctionOct 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE 4.5X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS PREPPED, THE DEVICE WAS BEING TRANSFERRED TO THE OPERATING TABLE AND THE STENT DISLODGED FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23193243 ↗
• MalfunctionDec 18, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE DEVICE WAS ADVANCED TO THE LESION AT THE VERTEBRAL ARTERY AND INFLATED AND THEN IT WAS NOTED THE STENT HAD DISLODGED IN THE PROTECTIVE SHEATH AS IT WAS NOT ON THE DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20964694 ↗
• MalfunctionFeb 17, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 4.5X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND PRESSURE WAS INCREASED TO 11 ATMOSPHERES (ATM), HOWEVER, THE STENT DID NOT FULLY DEPLOY. THE ENTIRE DELIVERY SYSTEM INCLUDING THE STENT WAS REMOVED FROM THE ANATOMY THROUGH THE GUIDING CATHETER AND A NEW SAME SIZE HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 18728237 ↗
• InjuryNov 14, 2022Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE VERTEBRAL ARTERY WITH MODERATE TORTUOSITY, HEAVY CALCIFICATION AND 80% STENOSIS. DURING ADVANCEMENT OF THE 4.5X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A SNARE WAS USED TO ATTEMPT TO RETRIEVE THE STENT, BUT IT FELL INTO A SMALL BRANCH OF THE INTERNAL ILIAC ARTERY AND WAS NOT REMOVED AS IT IS STUCK IN HEALTHY TISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15794924 ↗
• InjuryOct 24, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A NARROW LESION IN THE PROXIMAL RENAL ARTERY WITH CONCENTRIC STENOSIS. THE 4.5 X 12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WHEN THE SDS STARTED TO BE ADVANCED THROUGH THE LESION, THE STENT STUCK IN THE STENOSIS. THE STENT WAS NOT ADVANCING WITH THE SDS. WHEN THE SDS WAS REMOVED, THE STENT DISLODGED FROM THE BALLOON. A SHEATH WAS ADVANCED TO RETRIEVE THE STENT. A NON-ABBOTT STENT WAS USED TO TREAT THE LESION AND THE PATIENT WAS CONFIRMED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6974644 ↗