Herculink Elite 1011493-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648078002), received between Aug 10, 2018 and Sep 25, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE 5X12MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS TAKEN OUT OF THE PACKAGING, THE BALLOON WAS NOTED TO HAVE A HOLE AT THE TIP; THEREFORE, THE BES WAS NOT USED IN THE PROCEDURE. ANOTHER HERCULINK ELITE BES WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151585 ↗
• MalfunctionApr 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED WHEN REMOVING THE 5.0X12MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM FROM THE HOOP COIL IT WAS NOTED THAT THE STENT HAD DISLODGED. THE STENT WAS FOUNDED IN THE PROTECTIVE SHEATH. ANOTHER SAME SIZE HERCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763320 ↗
• MalfunctionFeb 12, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 5.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FELT RESISTANCE THROUGH THE 6FR INTRODUCER SHEATH. UPON REMOVAL FROM THE ANATOMY, BEFORE THE SDS REACHED THE LESION, THE STENT WAS NOTED TO HAVE STRUTS BENT IN AND OUT. ANOTHER 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. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS DISLOCATED ON THE DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691301 ↗
• InjuryApr 5, 2023Difficult to Remove; Migration; Difficult to Remove; Migration

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE ACCOUNT STATED THAT THE LESION TREATED HAVE HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE STENT WAS DEPLOYED AND PLACED IN THE TARGET LESION; HOWEVER, WAS MOVED PARTIALLY OUTSIDE THE TARGET LESION DURING REMOVING THE DELIVERY SYSTEM. THE VIATRAC BALLOON WAS USED TO POSITION THE HERCULINK STENT BACK TO THE TARGET LESION AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686601 ↗
• MalfunctionMar 8, 2023Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY THAT IS 80% STENOSED. THE 5.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. RESISTANCE WAS NOTED DURING ADVANCEMENT; HOWEVER, IT IS UNKNOWN WHAT THE DEVICE MET RESISTANCE WITH. THE STENT WAS OBSERVED TO HAVE MOVED ON THE BALLOON IN THE SHEATH AND FAILED TO CROSS THE LESION. THE SDS WAS REMOVED WITH THE STENT STILL ON THE SDS AND A NEW 5.0X12MM HERCULINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 16506432 ↗
• InjuryDec 6, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT ILIAC ARTERY WITH 95% STENOSIS, PRESENCE OF CALCIFICATION AND HEAVY TORTUOSITY. THE 5.0X12MM HERCULINK STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY AND FORCE WAS APPLIED TO TRAVERSE THE TORTUOSITY AND THE LESION RESULTING IN THE STENT COMING OFF THE BALLOON. A SNARE DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE STENT BUT WAS UNSUCCESSFUL. AN OMNILINK STENT WAS DEPLOYED TO CRUSH THE HERCULINK STENT IN THE LEFT ILIAC ARTERY. ANOTHER OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS REPORT OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15924701 ↗
• MalfunctionFeb 26, 2022Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 100% OCCLUDED OSTIAL SUPERIOR MESENTERIC ARTERY (SMA). THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED OVER A LONG SPARTACORE GUIDE WIRE. NO ISSUES WERE NOTED DURING ADVANCEMENT WITH THE GUIDE WIRE, BUT DIFFICULTY WAS NOTED ADVANCING THE HERCULINK ELITE DUE TO THE PATIENT ANATOMY, SO REMOVAL OF THE DEVICE WAS INITIATED; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. THE DEVICE WAS PULLED AND THE HERCULINK ELITE STENT DELIVERY SEPARATED AT A LOCATION OUTSIDE THE PATIENT ANATOMY. AFTER REMOVING THE PROXIMAL DEVICE, THE PROXIMAL GUIDE WIRE WAS CUT TO REMOVE THE HERCULINK ELITE SEPARATED SEGMENT. THE PROCEDURE CONTINUED USING THE SAME CUT GUIDE WIRE. A SECOND HERCULINK ELITE WAS THEN IMPLANTED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13609361 ↗
• InjuryAug 20, 2020Inflation Problem; Difficult or Delayed Activation; Inflation Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED RENAL ARTERY. PRE-DILATATION WAS PERFORMED TWICE AND THE HERCULINK STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET SITE. THE DELIVERY SYSTEM BALLOON WAS INFLATED TO DEPLOY THE STENT; HOWEVER, THE BALLOON DID NOT FULLY INFLATE AND THE STENT WAS NOT FULLY EXPANDED. THE STENT DELIVERY SYSTEM WAS REMOVED, WITH THE STENT REMAINING IN PLACE AT THE TARGET LESION. A DILATATION CATHETER WAS THEN ADVANCED INTO THE STENT AND WAS INFLATED TO FULLY EXPAND THE HERCULINK STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435130 ↗
• MalfunctionJul 15, 2019Off-Label Use; Difficult to Remove; Difficult to Advance; Off-Label Use; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE EMBOSHIELD NAV6 BAREWIRE WAS ADVANCED TO THE LEFT VERTEBRAL ARTERY. A VIATRAC BALLOON DILATATION CATHETER (BDC) WAS TRAVERSED OVER THE BAREWIRE AND THE BDC WAS USED WITHOUT INCIDENT. THE BDC WAS REMOVED. THE 5.0X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS LOADED ON TO THE BAREWIRE, BUT WAS UNABLE TO BE ADVANCED ON THE WIRE. THE SDS DID NOT ENTER THE INTRODUCER SHEATH. THE SDS WAS UNABLE TO BE REMOVED FROM THE BAREWIRE, SO THE BAREWIRE AND SDS WERE REMOVED TOGETHER AS A UNIT. OUTSIDE THE ANATOMY, THE SDS WAS ABLE TO BE REMOVED FROM THE BAREWIRE WITH A FAIR AMOUNT OF FORCE. ANOTHER BAREWIRE AND ANOTHER HERCULINK WERE USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. 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 8791266 ↗
• InjuryMar 1, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT NUMBER MW5083242 RECEIVED STATING THE FOLLOWING: DURING PROCEDURE, PATIENT NEEDED A STENT TO THEIR INFERIOR MESENTERIC ARTERY. WHILE TRYING TO PLACE A STENT, THE STENT CAME OFF THE BALLOON CATHETER AND HAD TO BE RETRIEVED WITH A SNARE. RETRIEVAL OF STENT WAS SUCCESSFUL, AND STENT WAS REMOVED FROM THE BODY SUCCESSFULLY. ADDITIONALLY, IT WAS REPORTED THAT THE LESION WAS 99% STENOSED, WITH CALCIFICATION AT THE OSTIUM OF THE VESSEL. RESISTANCE WAS MET DURING ADVANCEMENT TO THE LESION. WHEN THE STENT SYSTEM REACHED THE LESION, THE STENT DISLODGED. A DIFFERENT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS TRANSPORTED BACK TO ROOM IN STABLE CONDITION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383782 ↗
• MalfunctionAug 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKING OF A 5.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) THE DISTAL END OF THE STENT WAS NOTED TO BE PARTIALLY OFF OF THE BALLOON. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS OR THE DEVICE PACKAGING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW HERCULINK ELITE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7774846 ↗