Herculink Elite 1011499-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648078200), received between May 24, 2017 and Apr 24, 2026 — classified as 3 injuries, 10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT RENAL ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 7X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED IN THE 6FR GUIDING CATHETER. THE STENT DISLODGED AND WAS FLOATING IN THE VESSEL. A SNARE WAS USED TO RETRIEVE THE STENT. A 6X18 MM HERCULINK ELITE SDS WAS ALSO ADVANCED TO THE LESION AND RESISTANCE WAS NOTED IN THE 6FR GUIDING CATHETER. THE STENT BECAME DISPLACED BUT REMAINED ON THE DELIVERY SYSTEM. ANOTHER HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981722 ↗
• MalfunctionDec 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT VERTEBRAL ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 6X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. DURING POSITIONING, THE PROXIMAL MARKER OF THE HERCULINK SDS WAS LOCATED APPROXIMATELY 1 MM FROM THE SUBCLAVIAN ARTERY OSTIUM. AFTER DEPLOYMENT, THE PROXIMAL END OF THE STENT WAS OBSERVED TO BE 2 MM FROM THE OSTIUM, INDICATING A NOTICEABLE MIGRATION. THEREFORE THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM AND A NEW SAME SIZE DEVICE 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 23911271 ↗
• MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE DEVICE WAS LOADED ONTO A GUIDE WIRE PRIOR TO PREPARATION WITH CONTRAST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326806 ↗
• MalfunctionJan 27, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS RENAL ARTERY THAT IS 80% STENOSED. RESISTANCE WAS NOTED DUE TO THE GUIDING CATHETER WHEN ADVANCING THE 6.0X18MM HERCULINK ELITE STENT. THE STENT DISLODGED BEFORE REACHING THE LESION, BUT WAS SIMPLY WITHDRAWN TOGETHER WITH THE SHEATH. THERE WERE NO REPORTED 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 21242955 ↗
• MalfunctionJan 16, 2025Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RENAL ARTERY WITH MILD CALCIFICATION AND 80% STENOSIS. THE 6X18MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A COMMAND GUIDE WIRE, THEN PASSED THROUGH AN UNSPECIFIED SHEATH TO THE TARGET SITE; HOWEVER, THE SDS FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED AND A FLAT BEND WAS NOTED ON THE STENT. A SAME SIZE HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BUT NOT BETWEEN THE MARKERS. THE STRUTS AT THE DISTAL END OF THE STENT IMPLANT WERE LOCATED 4MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKER. THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED 1MM PASSED THE PROXIMAL EDGE OF THE PROXIMAL BALLOON MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170534 ↗
• MalfunctionJan 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 6.0X18MM HERCULINK STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE HOOP WITHOUT RESISTANCE WHEN THE STENT WAS NOTED TO HAVE MOVED ON THE BALLOON BUT WAS STILL CRIMPED. ANOTHER HERCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 21072363 ↗
• MalfunctionJun 27, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION AND TORTUOSITY IN THE RENAL ARTERY WITH A 6.0X18MM 135CM RX HERCULINK ELITE BALLOON EXPANDING STENT (BES). REPORTEDLY DURING DEVICE PREPARATION, THE TIP OF THE CATHETER WAS NOTED TO HAVE FALLEN OFF WHEN THE GUIDE WIRE LUMEN WAS FLUSHED; HOWEVER, THE DEVICE WAS STILL 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 19629442 ↗
• MalfunctionApr 3, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RENAL ARTERY. THE 6.0X18MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE COMMAND ES GUIDE WIRE HOWEVER THE SDS BECAME STUCK ON THE GUIDE WIRE AND COULD NOT MOVE. THE SDS AND GUIDE WIRE WERE REMOVED TOGETHER FROM THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO SEPARATE THE DEVICES OUTSIDE THE PATIENT, FORCE WAS APPLIED AND THE SDS DISTAL SHAFT BROKE. ANOTHER HERCULINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031342 ↗
• InjuryFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. DURING ADVANCEMENT OF THE 6X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THE STENT DISLODGED. A LARGE DIAMETER GUIDING CATHETER WAS ADVANCED IN ORDER TO RETRIEVE THE STENT. THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700178 ↗
• InjuryNov 17, 2021Deflation Problem; Off-Label Use; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deflation Problem; Off-Label Use; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERIOR MESENTERIC ARTERY (SMA). THE 6.0X18MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS SELECTED AS THE VESSEL SIZE MATCHED THE LESION. THE BESS WAS ADVANCED AND INFLATED; HOWEVER, THE STENT COULD NOT BE DEPLOYED AGAINST THE VESSEL WALL AND DISLODGED. THE BALLOON WAS ATTEMPTED TO BE DEFLATED, BUT WOULD NOT FULLY DEFLATE AND A SYRINGE WAS USED TO PULL NEGATIVE PRESSURE CONTINUOUSLY TO COMPLETELY DEFLATE THE BESS. THE BESS WAS WITHDRAWN AND THE SHAFT WAS NOTED TO BE KINKED. THE STENT MIGRATED TO THE ILIAC ARTERY AND BECAME STUCK. THE STENT REMAINS IN THE ANATOMY WITH NO TREATMENT PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12831813 ↗
• MalfunctionApr 30, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL RENAL ARTERY. A HI-TORQUE SPARTACORE GUIDEWIRE (GW) AND A HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WERE ADVANCED WITHOUT ISSUES AND THE HERCULINK WAS IMPLANTED. HOWEVER, WHEN REMOVING THE SDS, RESISTANCE WAS FELT WITH THE GW. THE SDS WAS PULLED OUT BY HAND WITH THE GUIDE WIRE STUCK IN THE SDS, AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566964 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT THE FOLLOWING NEW INFORMATION WAS RECEIVED: THE PATIENT CONFIRMED THAT SHE IS ALLERGIC TO CHROMIUM AND MANGANESE. THE STENT WAS SURGICALLY EXPLANTED /REMOVED FROM THE PATIENT ON (B)(6) 2018. THE HOT BURNING RASH IS GONE. THE ITCHING HAS DECREASED TO MORE OF A TOPICAL ITCH AND ALTHOUGH ANNOYING, IT IS MANAGEABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7254192 ↗
• MalfunctionMay 24, 2017Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method; Torn Material

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A TARGET LESION IN THE RIGHT RENAL ARTERY. THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS NOT FLUSHED PRIOR TO USE, AND WHEN ADVANCED OVER THE SPARTACORE GUIDE WIRE, RESISTANCE WAS FELT. THE DEVICE WAS REMOVED FROM THE GUIDE WIRE WITH DIFFICULTY, AND THE END OF THE GUIDE WIRE KINKED. IN ORDER TO REMOVE THE HERCULINK ELITE AND MAINTAIN VESSEL ACCESS, THE KINKED END OF THE GUIDE WIRE WAS CUT OFF. THE HERCULINK WAS EASILY REMOVED FROM THE GUIDE WIRE. THE HERCULINK ELITE WAS FLUSHED AND WAS ADVANCED OVER THE SAME GUIDE WIRE; HOWEVER, WHEN THE GUIDE WIRE WAS CUT, A BURR OCCURRED AT THE CUT END. THE BURR CAUSED A TEAR IN THE HERCULINK ELITE DELIVERY SYSTEM BALLOON AND THE DEVICE WAS REMOVED FROM THE GUIDE WIRE WITHOUT RESISTANCE. A SECOND HERCULINK ELITE STENT DELIVERY SYSTEM WAS THEN PREPARED, AND WAS FLUSHED APPROPRIATELY. THE DEVICE WAS ADVANCED OVER THE SAME CUT SPARTACORE GUIDE WIRE WITHOUT DIFFICULTY AND THE STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6589843 ↗