Herculink EliteRecalls & reported problems across all models

We found 23 models of Herculink Elite by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 170 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2016 and Sep 8, 2026 — classified as 1 death, 70 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (100 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Herculink Elite problems

Herculink Elite models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Herculink Elite 1011487-15

  STENT, RENAL
  27 reports
• Herculink Elite 1011487-12

  STENT, RENAL
  24 reports
• Herculink Elite 1011493-18

  STENT, RENAL
  1 death16 reports
• Herculink Elite 1011487-18

  STENT, RENAL
  13 reports
• Herculink Elite 1011499-18

  STENT, RENAL
  13 reports
• Herculink Elite 1011499-15

  STENT, RENAL
  12 reports
• Herculink Elite 1011493-12

  STENT, RENAL
  11 reports
• Herculink Elite 1011505-18

  STENT, RENAL
  11 reports
• Herculink Elite 1011493-15

  STENT, RENAL
  10 reports
• Herculink Elite 1011490-12

  STENT, RENAL
  6 reports
• Herculink Elite 1011505-15

  STENT, RENAL
  6 reports
• Herculink Elite 1011490-15

  STENT, RENAL
  4 reports
• Herculink Elite 1011490-18

  STENT, RENAL
  2 reports
• Herculink Elite 1011492-12

  STENT, RENAL
  2 reports
• Herculink Elite 1011496-12

  STENT, RENAL
  2 reports
• Herculink Elite 1011496-18

  STENT, RENAL
  2 reports
• Herculink Elite 1011498-18

  STENT, RENAL
  2 reports
• Herculink Elite 1011504-18

  STENT, RENAL
  2 reports
• Herculink Elite 1011492-15

  STENT, RENAL
  1 report
• Herculink Elite 1011499-12

  STENT, RENAL
  1 report
• Herculink Elite 1011502-12

  STENT, RENAL
  1 report
• Herculink Elite 1011502-15

  STENT, RENAL
  1 report
• Herculink Elite 1011502-18

  STENT, RENAL
  1 report

Recent Herculink Elite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  It was reported that out of packaging, the 4.0x15mm RX HERCULINK ELITE stent delivery system was prepped before the sheath/stylet removal. Resistance was met during removal of the sheath/stylet. The stent was loose and dislodged from the balloon. There was no patient involvement. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674579 ↗
• MalfunctionAug 26, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50463916 ↗
• MalfunctionJul 6, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, HEAVILY TORTUOUS RENAL ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 5.0 X 18 MM HERCULINK ELITE BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS) OVER THE 0.014 HT COMMAND GUIDE WIRE, RESISTANCE WAS MET AND DESPITE REPOSITIONING, THE SDS FAILED TO CROSS THE LESION. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE STENT ALONG THE GUIDE WIRE, RESULTING IN ENTANGLEMENT OF THE DEVICES. THE SDS AND GUIDE WIRE WERE WITHDRAWN SMOOTHLY THROUGH THE SHEATH. ONCE OUTSIDE THE ANATOMY, THE STENT AND BALLOON WERE NOTED TO BE SEPARATED FROM THE WHOLE SYSTEM. THE DEVICES WERE PULLED APART, AND THE GUIDE WIRE WAS INTENTIONALLY CUT IN AN ATTEMPT TO REMOVE IT FROM THE SDS WITH NO SUCCESS. A NEW UNSPECIFIED SDS AND GUIDE WIRE WERE 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 25719924 ↗
• MalfunctionJun 17, 2026Defective Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT RENAL ARTERY. THE 5.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE 118CM GUIDING CATHETER HOWEVER THE SDS DID NOT REACH THE LESION AS IT WAS THOUGHT THE LENGTH OF THE SDS WAS SHORTER THAN SPECIFIED OF 135CM. 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 25532036 ↗
• InjuryJun 2, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 5 X 18 MM HERCULINK STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT WITH THE GUIDING CATHETER AND TORTUOUS ANATOMY. THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A SECOND GUIDE WIRE AND A BALLOON WERE ADVANCED AND THE BALLOON WAS INFLATED TO GET ALL OF THE DEVICE OUT OF THE ANATOMY. ANOTHER HERCULINK STENT WAS USED TO COMPLETE THE PROCEDURE VIA THE LEFT RADIAL ACCESS. FINAL PATIENT OUTCOME WAS SUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361092 ↗
• 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 ↗
• MalfunctionApr 22, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, HEAVILY TORTUOUS RENAL ARTERY THAT IS 85% STENOSED. ONCE AT THE LESION PRIOR TO DEPLOYMENT, RESISTANCE WAS MET WITH THE GUIDING CATHETER AND THE BALLOON DISLODGED FROM THE 4.0X15MM HERCULINK BALLOON-EXPANDABLE (BES) STENT DELIVERY SYSTEM. THE BES WAS SIMPLY WITHDRAWN, AND ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE DEVICE WAS HANDLED AND THE STENT WAS LOST DURING TRANSPORTATION, LEAVING ONLY THE DELIVERY SYSTEM. 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 24956244 ↗
• 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 ↗
• 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 ↗
• InjuryJan 29, 2026Failure to Advance; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RENAL ARTERY. A 5.0X18MM HERCULINK ELITE BALLOON-EXPANDABLE STENT (BES) FAILED TO CROSS DUE TO ANATOMY, UPON REMOVAL, THE STENT DISLODGED AND MIGRATED TO THE DISTAL SEGMENT OF THE RIGHT FEMORAL ARTERY. A GUIDEWIRE AND SNARE WERE USED TO RETRIEVE THE STENT VIA A CROSSOVER SHEATH FROM THE LEFT FEMORAL ARTERY. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212001 ↗
• InjuryJan 27, 2026Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, RIGHT RENAL ARTERY. DURING ADVANCEMENT OF THE 4.0X18MM HERCULINK ELITE BALLOON-EXPANDABLE STENT (BES), RESISTANCE WAS MET DUE TO THE ANGLE OF THE ARTERY AND PRIOR TO REACHING THE LESION, THE STENT DISLODGED FROM THE BALLOON AND WAS SNARED. THE 4.0X15MM HERCULINK BES FAILED TO CROSS DUE TO ANATOMY AND A KINK ON THE DISTAL END OF THE STENT WAS NOTED. THE PROCEDURE WAS ABORTED AT THIS POINT. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191387 ↗
• MalfunctionJan 9, 2026Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS AND STENOSED LESION IN THE LEFT RENAL ARTERY. THE 5.0X18MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. DURING REMOVAL THE STENT STRUTS CAUGHT ON THE SHEATH, CAUSING THE STRUTS TO BEND. 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 24019301 ↗
• 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 ↗
• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT VERTEBRAL ARTERY. THE 4.0X12MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON. DURING RETRACTION OF THE SDS THE RIGHT RADIAL ARTERY WAS INJURED. AN INCISION WAS MADE AND THE DISLODGED STENT WAS REMOVED FROM THE ANATOMY. THE PROCEDURE WAS ABORTED AT THIS TIME. THE PATIENT WAS BROUGHT BACK AT A LATER DATE TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23605945 ↗

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