Herculink Elite 1011493-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648078026), received between Dec 9, 2016 and Aug 26, 2026 — classified as 1 death, 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 THE SDS AND GUIDE WIRE WERE WITHDRAWN SMOOTHLY THROUGH THE SHEATH.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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 5, 2024Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY. THE 5.0X18MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE ANATOMY HOWEVER RESISTANCE WAS MET WITH THE 6FR RENAL ARTERY SHEATH AND THE ANATOMY AND THE STENT DISLODGED FROM THE BALLOON. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT. ANOTHER STENT 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 20146265 ↗
• DeathJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024 THE 5X18 MM RX HERCULINK ELITE STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY. ON 05/14/2024 DURING THE STUDY SITE'S REVIEW OF THE MEDICAL RECORD, IT WAS NOTED THAT THE PATIENT EXPIRED OF UNKNOWN CAUSE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 19448939 ↗
• InjuryAug 17, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE 70% STENOSED, SEVERELY TORTUOUS LEFT RENAL ARTERY. WHILE ADVANCING THE 5.0X18MM HERCULINK ELITE STENT DELIVERY SYSTEM, THE STENT DISLODGED FROM THE BALLOON. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND THE STENT SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246050 ↗
• MalfunctionMar 8, 2022Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED VESSEL IN THE RIGHT VERTEBRAL ARTERY. THE 5.0X18MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) BALLOON HAD NO RESISTANCE DURING ADVANCEMENT, HOWEVER, FAILED TO INFLATE AND THE STENT FAILED TO DEPLOY. THE SDS WAS REMOVED AND THE BALLOON WAS EXAMINED AND WAS NOTED TO BE BROKEN AND REMAINS IN ONE PIECE WITH LEAKAGE [RUPTURE]. THE SDS WAS SOAKED PRIOR TO USE, HOWEVER, IT WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY. ANOTHER HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 13685860 ↗
• MalfunctionJan 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED DE NOVO RENAL ARTERY THAT IS 70% STENOSED. A 5.0X18MM RX HERCULINK ELITE STENT DELIVERY SYSTEM COMPLETELY FAILED TO DEPLOY. DEVICE WAS REMOVED AND ANOTHER SAME SIZE HERCULINK ELITE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158010 ↗
• MalfunctionSep 30, 2020Break; Leak/Splash; Material Separation; Break; Leak/Splash; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT RENAL ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT 4.0X20MM BALLOON DILATATION CATHETER AT 12 ATMOSPHERES. THE 5.0X18MM HERCULINK STENT DELIVERY SYSTEM (SDS), WAS ADVANCED TO THE LESION AND WAS INFLATED TO 10 ATMOSPHERES, DELIVERING THE STENT TO THE LESION; HOWEVER, A LEAK WAS NOTED COMING FROM THE HUB. THE SDS WAS REMOVED AND THE HUB WAS OBSERVED TO BE CRACKED AND THEN THE HUB BROKE OFF. THE HERCULINK STENT WAS POST DILATED WITH A NON-ABBOTT BALLOON AT 14 ATMOSPHERES. THE PATIENT WAS FINE. 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 10610696 ↗
• InjuryNov 23, 2018Detachment of Device or Device Component; Positioning Problem

  PATIENT WAS SCHEDULED FOR PTA OF CELIAC ARTERY AN SUPERIOR MESENTERIC ARTERY. DR. (B)(6) STENTED THE CELIAC AND THEN WE MOVED ON THE SUPERIOR MESENTERIC. DOCTOR BALLOONED SMA AND THEN PROCEEDED TO TRY AND STENT THE SMA. THE STENT CAME OFF OF THE DEPLOYMENT BALLOON BUT REMAINED ON THE WIRE. WE WERE ABLE TO GET THE STENT BACK TO THE SHEATH AND INTO THE TISSUE TRACT, HOWEVER WE WERE UNABLE TO GET IT THROUGH THE SOFT TISSUE TRACT SO DR. (B)(6) ASKED DR. (B)(6) TO DO A CUT DOWN ON THE RIGHT GROIN TO REMOVE THE UNDEPLOYED STENT. DR. (B)(6) SUCCESSFULLY WAS ABLE TO REMOVE THE STENT AND PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT REMAINED AWAKE, ALERT AND STABLE FOR THE ENTIRE PROCEDURE AND WAS MADE AWARE OF THE SITUATION AND WAS ABLE TO TALK TO THE ANESTHESIOLOGIST AND SURGEON PRIOR TO BEING PUT TO SLEEP FOR SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102078 ↗
• MalfunctionMay 25, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT RENAL ARTERY THE 5.0 X 18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON-ABBOTT GUIDE CATHETER, BUT MET RESISTANCE AND WOULD NOT ADVANCE. THE SDS MET RESISTANCE DURING REMOVAL; SO THE SDS, GUIDE CATHETER, AND GUIDE WIRE WERE REMOVED TOGETHER AS A SYSTEM FROM THE ANATOMY. THE VESSEL WAS RE-WIRED AND A DIFFERENT SDS WAS USED IN THE PROCEDURE WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546130 ↗
• MalfunctionMay 22, 2018Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ILIAC ARTERY. AS A 5.0 X 18MM HERCULINK ELITE STENT DELIVERY SYSTEM WAS BEING ADVANCED, THE PHYSICIAN DEEMED IT NECESSARY TO USE A DIFFERENT SIZE DEVICE. DURING REMOVAL, THE DELIVERY SYSTEM GOT STUCK ON THE GUIDING CATHETER (GC). THE DEVICE WAS REMOVED AS A SINGLE UNIT INCLUDING THE GC. ANOTHER HERCULINK WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 7535748 ↗
• InjuryJan 23, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SEVERELY CALCIFIED INFERIOR MESENTERIC ARTERY (IMA). THE VESSEL WAS PRE-DILATED SUCCESSFULLY WITH A 3.0X40 ARMADA 14 BALLOON DILATATION CATHETER. THE 5.0X18 MM HERCULINK STENT SYSTEM FAILED TO CROSS THE TARGET LESION DUE TO THE PATIENT ANATOMY. WHEN REMOVING THE HERCULINK STENT SYSTEM, THE STENT DISLODGED FROM THE BALLOON. A SNARE DEVICE WAS USED, THE STENT WAS SNARED CLOSE TO THE GUIDE CATHETER AND COULD NOT BE RETRIEVED ANY FURTHER; A CUT DOWN HAD TO BE PERFORMED TO SUCCESSFULLY RETRIEVE THE STENT. THE PROCEDURE WAS ABORTED. THERE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213711 ↗
• MalfunctionDec 9, 2016Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL RENAL ARTERY. A 5.0 X 18 MM HERCULINK ELITE STENT DELIVERY SYSTEM COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND WHEN REMOVING THE DEVICE THE STENT GOT STUCK AT THE DISTAL END OF THE GUIDING CATHETER AND THE PROXIMAL END OF THE STENT FLARED. THE DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDING CATHETER WHICH CAUSED THE DISTAL END OF THE GUIDE TO FOLD BACK ON ITSELF SO THE ENTIRE SYSTEM INCLUDING THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. ANOTHER GUIDE WIRE, GUIDING CATHETER AND 5.0 X 18 MM HERCULINK ELITE WERE SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6159653 ↗