Herculink Elite 1011493-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648078019), received between Feb 15, 2019 and Jun 17, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 20, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT VERTEBRAL ARTERY. A 5X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED TO THE LESION OVER A 2 METER NON-ABBOTT GUIDEWIRE; HOWEVER, THE STENT WAS NOTED TO BECOME DISLODGED. A NON-ABBOTT BALLOON CATHETER WAS USED TO FULLY EXPAND THE DISLODGED STENT IN THE TARGET LESION AND A 4X20MM VIATRAC BALLOON DILATATION CATHETER WAS USED TO POST-DILATE THE STENT. ANOTHER SAME SIZED HERCULINK ELITE STENT WAS THEN DEPLOYED AT THE DISTAL END OF THE DEPLOYED STENT COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986868 ↗
• MalfunctionApr 30, 2024Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT VERTEBRAL ARTERY. THE 5.0X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE BALLOON WOULD NOT EXPAND AFTER PRESSURE WAS APPLIED RESULTING IN THE STENT FAILING TO DEPLOY. A NEW 5X12MM HERCULINK STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215586 ↗
• MalfunctionJan 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN FLUSHING THE 5.0X15MM HERCULINK STENT DELIVERY SYSTEM (SDS) THE STENT DISLODGED INSIDE THE TIP OF THE SHEATH. THE SDS WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE HERCULINK SDS WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589065 ↗
• MalfunctionJun 2, 2022Leak/Splash; Material Twisted/Bent; Leak/Splash; Material Twisted/Bent

  IT WAS REPORTED THAT THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS REMOVED FROM THE DISPENSER HOOP, AND WAS NOTED TO BE BENT. THE DEVICE WAS UNABLE TO BE PREPARED FOR USE AS AIR WAS SEEN DURING PULLBACK. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED DILATATION CATHETER WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575402 ↗
• MalfunctionMar 2, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION LOCATED IN A MODERATELY CALCIFIED AND DIFFICULT ANGLED RIGHT RENAL ARTERY. A HI-TORQUE (HT) SPARTACORE GUIDE WIRE WAS PLACED IN POSITION. THE HERCULINK STENT SYSTEM HAD RESISTANCE WITH THE GUIDE WIRE DURING ADVANCEMENT BUT THE PHYSICIAN GOT IT INTO POSITION. HOWEVER, THE PHYSICIAN LOST ACCESS TO THE ARTERY AND THE GUIDE WIRE POPPED FROM THE ARTERY BUT DID NOT DAMAGE THE ARTERY. THE STENT COULDN'T BE REMOVED FROM THE GUIDE WIRE SO THE STENT AND THE GUIDE WIRE WERE PULLED AS ONE UNIT. THE PROCEDURE WAS ABORTED DUE TO THE ANATOMICAL CHALLENGES. 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 13653599 ↗
• InjuryJun 15, 2021Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE MODERATELY CALCIFIED, HEAVILY CALCIFIED RIGHT RENAL ARTERY THAT WAS 50% STENOSED. THE 5.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM WAS PRESSURIZED TO 14ATM BUT FAILED TO INFLATE. THE DEVICE WAS THEN PRESSURIZED TO 20ATM AND THE STENT ONLY PARTIALLY OPENED. IT WAS THEN ATTEMPTED TO PULL BACK THE BALLOON, BUT RESISTANCE WAS NOTED. THE DELIVERY CATHETER WAS REMOVED USING THE GUIDING CATHETER. IT WAS OBSERVED VIA X-RAY THAT THE STENT WAS NOT COMPLETELY OPENED. AN UNSPECIFIED BALLOON CATHETER WAS USED TO FULLY DEPLOY THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001749 ↗
• MalfunctionDec 28, 2020Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE 5.0X15MM HERCULINK ELITE BALLOON WAS OBSERVED TO BE RUPTURED WHEN THE DEVICE WAS FLUSHED AND AIR ASPIRATION WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT. A NEW 5.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM 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 Patient Involvement

  MAUDE report 11083424 ↗
• MalfunctionApr 29, 2019Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 5.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED WHEN THE STENT WAS NOTED TO BE MISSING. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH. THE SDS WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. 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 8560852 ↗
• MalfunctionFeb 15, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY. THE 5.0 MM X 15 MM X 135 CM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE TARGET LESION AND IN AN ATTEMPT TO REPOSITION THE DEVICE; THE SDS WAS RETRACTED AND RESISTANCE WAS FELT WITH THE GUIDE CATHETER. THE STENT WAS NOT IMPLANTED. THE SDS AND GUIDE CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. A NEW HERCULINK ELITE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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 8345271 ↗