Herculink Elite 1011505-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648078385), received between Oct 22, 2018 and Apr 17, 2026 — classified as 6 injuries, 5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING PREPARATION OF THE 7.0X18MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS MET ADVANCING THE DEVICE OVER THE 0.014 GUIDE WIRE. A CLEAR FILM WAS NOTED AROUND THE STENT. FORCE WAS REQUIRED TO REMOVE THE SDS FROM THE GUIDE WIRE. A NEW HERCULINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED 2MM DISTALLY FROM ITS ORIGINAL CRIMPED POSITION. THERE ARE CRIMP MARKS NOTED ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910615 ↗
• MalfunctionApr 16, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RENAL VESSEL. THE 7.0X18MM HERCULINK BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS) WOULD NOT FULLY TRACK OVER AN UNSPECIFIED 0.014 GUIDEWIRE. THE SDS WOULD TRACK AND THEN GET STUCK. RESISTANCE WAS NOTED DURING REMOVAL DUE TO THE GUIDEWIRE; THEREFORE, THE HERCULINK STENT AND GUIDEWIRE WERE REMOVED AS A UNIT. A NEW UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24899621 ↗
• InjuryJan 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY. THE 7X18MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, THE STENT BECAME DISLODGED. THEREFORE, A SNARE DEVICE WAS USED TO RETRIEVE THE STENT. AN UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279068 ↗
• InjuryDec 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MESENTERIC ARTERY. A 7X18MM RX HERCULINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED INTO THE ANATOMY WITH NO RESISTANCE NOTED, HOWEVER, THE STENT WAS NOTED TO BE DISLODGED. THE DISLODGED STENT WAS IMPLANTED IN THE VESSEL WALL IN THE ILIAC ARTERY, AND ANOTHER SAME SIZED HERCULINK BES WAS DEPLOYED TO TREAT THE TARGET LESION IN THE MESENTERIC ARTERY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. THE HERCULINK ELITE STENT WAS NOTED TO BE DISLODGED IN THE ILIAC ARTERY. THE DISLODGED STENT WAS IMPLANTED IN THE VESSEL WALL IN THE ILIAC ARTERY USING AN ADDITIONAL UNKNOWN DILATATION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20929690 ↗
• MalfunctionJul 10, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE 7X18 MM HERCULINK ELITE STENT WAS DEPLOYED IN THE INTENDED LOCATION OF THE SUBCLAVIAN ARTERY. WHEN THE DELIVERY SYSTEM BALLOON WAS DEFLATED, IT NOT COMPLETELY DEFLATE AND THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE GUIDE SHEATH. THE DELIVERY SYSTEM WAS ULTIMATELY REMOVED AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713568 ↗
• InjuryAug 16, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERIOR MESENTERIC ARTERY. THE VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON. THE 7.0X18MM HERCULINK ELITE BALLOON EXPANDABLE STENT WAS ADVANCED AND DEPLOYED AT NOMINAL PRESSURE. THE STENT WAS DEPLOYED SUCCESSFULLY. THE DELIVERY SYSTEM WAS PULLED BACK TO THE OSTIUM OF THE VESSEL AND INTO THE AORTA, RE-INFLATED TO 15 ATMOSPHERES TO ASSURE PROXIMAL APPOSITION TO THE VESSEL, BUT THE BALLOON RUPTURED. THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED AND RESISTANCE WAS MET AS PART OF THE BALLOON BECAME CAUGHT WITH THE EDGE OF THE STENT. A PIECE OF THE RUPTURED BALLOON SEPARATED FROM THE DEVICE; HOWEVER, A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATION PORTION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559873 ↗
• InjuryMar 2, 2021Difficult to Advance; Device Dislodged or Dislocated; Activation Failure; Difficult to Advance; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIGHT LESION LOCATED IN THE RIGHT COMMON ILIAC ARTERY, THAT WAS NOT PREDILATED. THE RX HERCULINK STENT SYSTEM WAS ADVANCED, POSSIBLY WITH RESISTANCE THROUGH THE 6F RADIAL SHEATH TO THE LESION AND DURING DEPLOYMENT, RESISTANCE WAS NOTED AND THE STENT DISLODGED. THE STENT WAS CRUSHED AGAINST THE VESSEL WALL AND AN OMNILINK STENT WAS IMPLANTED TO COVER THE CRUSHED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11402546 ↗
• InjuryMar 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LEFT EXTERNAL ILIAC ARTERY. A HERCULINK ELITE 7/18MM STENT WAS INSERTED AND DEPLOYED WITHOUT ISSUES. HOWEVER, AFTER DEPLOYMENT, A FRAGMENT OF THE BALLOON DELIVERY CATHETER WAS NOTED IN THE ANATOMY. THEREFORE, A SNARE WAS INSERTED, AND THE FRAGMENTATION WAS SUCCESSFULLY REMOVED. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11402346 ↗
• InjuryOct 26, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RENAL ARTERY. THE 7.0X18MM HERCULINK ELITE STENT DELIVERY SYSTEM MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE STENT DISLODGED. THE DISLODGED STENT WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENTS ANATOMY. ANOTHER HERCULINK WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737791 ↗
• MalfunctionJun 15, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT RENAL ARTERY. THE LESION WAS PRE-DILATED AND THE 7X18MM HERCULINK ELITE WAS INFLATED WITHOUT ISSUE. HOWEVER, RESISTANCE WAS MET AND WAS UNABLE TO REMOVE THE HERCULINK AS IT WAS STUCK ON THE TIP OF THE GUIDE CATHETER. ALL DEVICES WERE REMOVED TOGETHER. 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 10153618 ↗
• MalfunctionOct 22, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT RENAL ARTERY. THE 7.0 X 18 MM HERCULINK STENT DELIVERY SYSTEM (SDS) WAS PREPPED. THE DEVICE WAS FLUSHED OUTSIDE THE PATIENT ANATOMY AND ADVANCED OVER THE GUIDE WIRE. ONCE INSIDE THE GUIDE CATHETER, NEGATIVE WAS PULLED. THE DEVICE WAS ADVANCED INTO THE ANATOMY AND WAS ABLE TO CROSS THE LESION. THE BALLOON WAS INFLATED AND IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IMAGING WAS PERFORMED TO LOCATE THE DISLODGED STENT, BUT WAS NOT FOUND IN THE ANATOMY, ON THE SDS, ON THE GUIDE WIRE OR IN THE GUIDING CATHETER. THE HERCULINK DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT STENT DELIVERY SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PREPARATION TABLE AND PROTECTIVE SHEATH WERE LOOKED AT BUT THE STENT WAS NOT FOUND. THE PHYSICIAN IS CERTAIN THAT THE STENT IS NOT IN THE PATIENT ANATOMY. ADDITIONALLY, IT WAS NOT NOTED IF THE STENT WAS PRESENT ON THE DELIVERY SYSTEM DURING DEVICE PREPARATION OR IF IT WAS COMPLETELY MISSING FROM THE STENT DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992645 ↗