Herculink Elite 1011499-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648078194), received between Nov 11, 2016 and Apr 21, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT RENAL ARTERY. A 6.0X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT WAS ATTEMPTED TO BE DEPLOYED AS IT WAS INFLATED TO 11 ATMOSPHERES; HOWEVER, THE STENT REMAINED ON THE DELIVERY SYSTEM AND WAS UNABLE TO RELEASE THE STENT FULLY. ANOTHER HERCULINK WAS USED TO SUCCESSFULLY 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 21876749 ↗
• InjuryFeb 18, 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 MILDLY CALCIFIED, HEAVILY TORTUOUS MESENTERIC ARTERY. DURING ADVANCEMENT OF THE 6.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET WITH AN UNSPECIFIED 6F SHEATH AND THE STENT DISLODGED FROM THE SDS. AN ATTEMPT WAS MADE TO SNARE THE STENT BUT WAS UNSUCCESSFUL. THE STENT WAS PULLED INTO THE ILIAC ARTERY AND A 7.0X24MM NON-ABBOTT STENT WAS USED TO COVER THE ENTIRE HERCULINK STENT. THERE WERE NO ADVERSE PATIENT SEQUELA; HOWEVER, A CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21404851 ↗
• MalfunctionMay 15, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RENAL ARTERY WITH 70% STENOSIS. THE 6.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. WHEN THE STENT WAS BEING RELEASED IT WAS NOTED TO BE BENT; THEREFORE, THE SDS COULD NO LONGER BE USED AND WAS REPLACED. ANOTHER UNSPECIFIED STENT 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 16930931 ↗
• MalfunctionFeb 14, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT RENAL ARTERY WITH SEVERE ANGULATION. THE 6.0X15MM RX HERCULINK ELITE STENT WAS ADVANCED; HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND THE STENT WAS CRIMPED ON THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. 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 16371845 ↗
• MalfunctionNov 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X15 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THE TIP OF THE STENT COME OFF. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NEW SAME SIZE HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 15874657 ↗
• MalfunctionApr 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE 6X15MM HERCULINK ELITE FROM THE PACKAGING THE TIP WAS NOTED TO BE SEPARATED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115866 ↗
• MalfunctionSep 29, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKING OF A 6X15MM HERCULINK STENT, IT WAS NOTED THAT THE STENT IMPLANT WAS LOOSE ON THE BALLOON (STILL REMAINING ON THE DELIVERY SYSTEM). THERE WERE NO ISSUES NOTED WITH THE CHIPBOARD BOX OR DISPENSER HOOP COIL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME SIZED DEVICE 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 12546889 ↗
• InjuryOct 2, 2020Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERIOR MESENTERIC ARTERY. THE VESSEL WAS NOT PREDILATED. A HERCULINK ELITE WAS ADVANCED OVER A SPARTACORE GUIDE WIRE WITHOUT ISSUE. THE STENT WAS DEPLOYED. AFTER STENT DEPLOYMENT AND UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT IMPLANT MIGRATED OUTSIDE THE TARGET LESION TO THE AORTA. A LARGER BALLOON WAS ADVANCED TO PUSH THE STENT IMPLANT BACK TO THE SUBCLAVIAN ARTERY, WHICH WAS SUCCESSFUL ALTHOUGH THIS WASN'T THE INTENDED ARTERY OF TREATMENT. THE STENT IMPLANT WAS BALLOONED AND IMPLANTED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. THE PHYSICIAN DEEMED THAT THE SUPERFICIAL MESENTERIC ARTERY WAS TREATED WITH BALLOONING AND NO FURTHER INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10623315 ↗
• MalfunctionApr 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION DISTAL TO THE TORTUOUS OSTIUM OF THE RENAL ARTERY WITH NO CALCIFICATION. A 5F NON-ABBOTT SHEATH WAS PLACED PAST THE LESION IN ORDER TO ASSIST WITH CROSSING THE OSTIUM. A 6.0 X 15 MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE SHEATH WITH NO REPORTED RESISTANCE. ON ATTEMPTING TO WITHDRAW THE SHEATH SLIGHTLY TO ALLOW THE STENT TO BE DEPLOYED AT THE LESION, IT WAS NOTED THAT THE STENT APPEARED LOOSE ON THE BALLOON OF THE SDS. IN ORDER TO PREVENT THE STENT DISLODGING, NO FURTHER REPOSITIONING OF THE SDS WAS PERFORMED AND THE STENT WAS DEPLOYED. THE SITE OF THE DEPLOYMENT WAS AT THE DISTAL END OF THE LESION LEAVING A PART OF THE PROXIMAL LESION UNCOVERED. A SECOND UNSPECIFIED STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE REMAINDER OF THE LESION AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540354 ↗
• InjuryFeb 12, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY (CFA). THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER. THE 6.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH FORCE APPLIED; HOWEVER, FAILED TO CROSS THE LESION. DURING WITHDRAWAL OF THE SDS, THE STENT DISLODGED. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A NEW HERCULINK ELITE. 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 8330890 ↗
• MalfunctionNov 17, 2016Difficult to Remove; Unstable; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MILDLY CALCIFIED, DE NOVO LESION IN A VERY TORTUOUS, 90 DEGREE ANGLED OSTEAL PROXIMAL SUPERIOR MESENTERIC ARTERY, A 4.0MM X 15MM X 135CM RX HERCULINK ELITE RENAL STENT SYSTEM WAS ADVANCED THROUGH A 6FR NON-ABBOTT 55CM SHEATH WITHOUT RESISTANCE AND WAS ADVANCED TO THE LESION WITHOUT ISSUE, BUT THE RX HERCULINK ELITE WAS UNABLE TO COMPLETELY CROSS THE LESION DUE TO THE 90 DEGREE VESSEL ANGLE. THUS, THE RX HERCULINK ELITE WAS PULLED BACK TO THE OSTEUM FOR BETTER POSITIONING BEFORE ATTEMPTING TO CROSS AGAIN. WHEN PULLING THE RX HERCULINK ELITE BACK TO THE OSTEUM WITHOUT RESISTANCE, THE STENT STRUTS BECAME CAUGHT ON THE DISTAL EDGE OF THE SHEATH, RESULTING IN THE STENT BEING MANGLED AND THE STENT SHIFTING DISTALLY OUTSIDE OF THE BALLOON MARKERS, BUT NO STENT DISLODGEMENT. IN ORDER TO RETRACT THE RX HERCULINK ELITE THROUGH THE SHEATH, THE RX HERCULINK ELITE WAS ADVANCED SLIGHTLY THEN MANEUVERED GENTLY AND COMPLETELY BACK INSIDE OF THE SHEATH, THEN WAS RETRACTED THROUGH THE SHEATH AND OUT OF THE ANATOMY WITHOUT RESISTANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 4.0X18 RX HERCULINK ELITE WITH THE SAME SHEATH. THERE WERE NO ADVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111628 ↗
• MalfunctionNov 11, 2016Break; Physical Property Issue

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RENAL ARTERY. DURING ADVANCEMENT OF THE 6.0 X 15 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) IT WAS OBSERVED ON ANGIOGRAPHY THAT THERE WAS A BUCKLING OR BOWING OF THE DISTAL END OF THE CATHETER AND WHAT APPEARED TO BE A SHORT WIRE STICKING OUT PROXIMAL TO THE RAPID EXCHANGE PORT. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT. THE SDS WAS REMOVED FROM THE ANATOMY IN ONE PIECE WITHOUT ANY ADVERSE PATIENT EFFECTS. IT WAS BELIEVED THAT EITHER THE INNER MEMBER HAD SEPARATED AND THAT COULD BE THE SMALL WIRE THAT IS STICKING OUT FROM THE SHAFT. A NEW SAME SIZE HERCULINK SDS WAS USED TO SUCCESSFULLY COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6096159 ↗