Herculink Elite 1011505-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648078378), received between Jan 18, 2019 and Aug 7, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Difficult to Remove; Malposition of Device; Patient-Device Incompatibility; Difficult to Remove; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT RENAL ARTERY THAT IS 95% STENOSED. DURING DEPLOYMENT OF A 7.0X15MM HERCULINK ELITE BALLON-EXPANDABLE STENT (BES), THE STENT SUCCESSFULLY DEPLOYED AT 14 ATMOSPHERES, BUT MISSED THE TARGET LESION AND WAS NOT FULLY APPOSED TO THE VESSEL WALL. A SECOND 6.0X12MM HERCULINK STENT WAS DEPLOYED AT 14 ATMOSPHERES AND SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE 6.0X12 HERCULINK BALLOON WAS COMPLETELY DEFLATED AND DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE 7.0X15MM HERCULINK BES WAS MOVED TO THE DISTAL RENAL ARTERY DUE TO MOVEMENT OF AN UNSPECIFIED GUIDE WIRE. A 7X40MM JADE BALLOON WAS USED TO POST DILATE THE 6X12MM BES. THE SAME 7X40MM JADE BALLOON WAS USED TO EMBED THE 7.0X15MM HERCULINK BES INTO THE DISTAL RENAL ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22739981 ↗
• InjuryJul 22, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 7.0/X15MM HERCULINK ELITE STENT WAS TO BE USED TO TREAT THE LEFT EXTERNAL ILIAC WITH HEAVY CALCIFICATION. HOWEVER, PRIOR TO REACHING THE TARGET LESION, RESISTANCE WAS FELT DUE TO THE HEAVY CALCIFICATION AND THE STENT DISLODGED IN THE ANATOMY. THE DISLODGED STENT WAS SNARED AND THE PROCEDURE WAS COMPLETED WITH AN OMNILINK STENT. THERE WERE NO ADVERSE PATENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794681 ↗
• InjuryJul 6, 2021Break; Leak/Splash; Difficult or Delayed Activation; Break; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED AND MILDLY CALCIFIED LESION IN THE SUPERIOR MESENTERIC ARTERY. THE 7.0X15MM HERCULINK ELITE BALLOON-EXPANDABLE STENT SYSTEM WAS PREPARED PRIOR TO USE WITHOUT ISSUES. DURING DEPLOYMENT OF THE STENT IT WAS NOTED THAT THE HUB WAS BROKEN/CRACKED AND A LEAK WAS NOTED WHICH DIDN¿T ALLOW FOR FULL DEPLOYMENT OF THE STENT. THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, POST-DILATATION WAS REQUIRED TO FULLY DEPLOY THE STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125256 ↗
• MalfunctionApr 26, 2021Break; Leak/Splash; Off-Label Use; Break; Leak/Splash; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 7X15MM HERCULINK WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 4 ATMOSPHERES, WHEN LEAKAGE WAS NOTED COMING FROM THE HUB DUE TO A CRACK. AN UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY 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 11729147 ↗
• InjuryMar 9, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: THE PATIENT HAD LEFT SUBCLAVIAN STENOSIS INVOLVING THE OSTIUM OF THE LEFT VERTEBRAL ARTERY. TO INDUCE RETROGRADE VERTEBRAL FLOW THROUGHOUT THE CASE, THE OPERATING PHYSICIAN OPTED TO PLACE A MOMA DEVICE WITHIN THE PROXIMAL SUBCLAVIAN ARTERY. THE DISTAL BALLOON WAS REMOVED AND ONLY THE PROXIMAL OCCLUSION WAS PERFORMED. AFTER STABILIZING THE MOMA DEVICE, THE PROXIMAL BALLOON WAS INFLATED IN THE VERY PROXIMAL LEFT SUBCLAVIAN ENSURING RETROGRADE FLOW TO THE LEFT VERTEBRAL. THE LEFT SUBCLAVIAN ARTERY WAS SUCCESSFULLY STENTED WITH A RX HERCULINK ELITE 7 X 15 STENT. UPON REMOVAL OF THE INITIAL HERCULINK STENT BALLOON THE BALLOON RUPTURED AND A VERY SMALL PORTION OF THE DISTAL BALLOON MAY HAVE BEEN SHEARED OFF BY MOMA DEVICE. HOWEVER, NO EVIDENCE OF EMBOLIZATION WAS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS AND WAS NOTIFIED BY THE PHYSICIAN. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11448806 ↗
• InjuryJan 18, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE LEFT RENAL ARTERY. A 7.0 X 15 MM HERCULINK ELITE STENT DELIVERY SYSTEM WAS BEING ADVANCED TO THE LESION WITH NO RESISTANCE WHEN THE UNSPECIFIED GUIDE LOST POSITIONING. ON ATTEMPTING TO REPOSITION THE GUIDE, CONTACT WITH THE STENT WAS MADE WHICH RESULTED IN THE STENT STRUTS FLARING AND THE STENT DISLODGING IN THE FEMORAL ARTERY. A CUT DOWN WAS PERFORMED TO REMOVE THE DISLODGED STENT. THE PATIENT LOST 400 ML OF BLOOD DURING THE CUT DOWN. THE ACCESS SITE / CUT DOWN SITE WAS CLOSED USING TWO PROGLIDE CLOSURE DEVICES. NO FURTHER INTERVENTION WAS PERFORMED FOR THE RENAL ARTERY AT THE TIME. POST PROCEDURE THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INTERVENTION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8262722 ↗