Herculink Elite 1011487-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648077845), received between May 5, 2017 and Jan 27, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 7, 2025Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT VERTEBRAL ARTERY THAT IS 85% STENOSED. THE 4.0X18MM HERCULINK WAS ADVANCED OVER AN UNSPECIFIED .014 GUIDE WIRE; HOWEVER, ONCE THE HERCULINK WAS DEPLOYED THE STENT MIGRATED TO COMMON INTEROSSEOUS ARTERY AND WAS EMBEDDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22416018 ↗
• MalfunctionJul 1, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE RENAL ARTERY. THE 4X18MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THEN UNDER ANGIOGRAPHY, IT WAS NOTED THAT THE STENT DISLODGED BUT REMAINED ON THE DELIVERY SYSTEM. THEREFORE, THE BES WAS REMOVED WITH THE STENT FROM THE PATIENT. A 4X15MM HERCULINK STENT WAS USED INSTEAD TO COMPLETE TREATMENT. 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 22376115 ↗
• MalfunctionMar 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AFTER FLUSHING THE 4.0X18MM HERCULINK STENT DELIVERY SYSTEM WAS REMOVED FROM THE HOOP; HOWEVER, THE STENT DISLODGED AND IN THE PROTECTIVE SHEATH. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998662 ↗
• MalfunctionNov 1, 2023Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.0X18MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE, HOWEVER, THE STENT COULD NOT BE DEPLOYED AT ALL AFTER THE BALLOON WAS PRESSURIZED AT AN UNKNOWN PRESSURE SUSPECTING THE BALLOON OF HAVING A LEAK. ANOTHER SAME SIZE HERCULINK ELITE STENT 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 18050304 ↗
• MalfunctionOct 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN TAKING THE 4X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT HAD MOVED ON THE DELIVERY SYSTEM AFTER THE STYLET/PROTECTIVE SHEATH WERE REMOVED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER DEVICE 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 17958735 ↗
• MalfunctionJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THE STENT WAS COMING OFF OF THE BALLOON. THERE WAS NO MANIPULATION OF THE STENT AT ANY POINT AND THE SDS WAS PREPPED AFTER STYLET REMOVAL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A CORONARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159570 ↗
• MalfunctionSep 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY TORTUOUS, 90% STENOSED LEFT RENAL ARTERY. A 4X18MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE, BUT THE BALLOON COMPLETELY FAILED TO INFLATE. THE STENT WAS REMOVED WITH THE SDS, AND A SAME SIZED HERCULINK ELITE STENT 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 12533791 ↗
• MalfunctionJun 4, 2021Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY CALCIFIED, MILDLY TORTUOUS LEFT VERTEBRAL ARTERY. THE 4.0X18 MM HERCULINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND UPON INFLATION OF THE BALLOON, IT WAS FOUND THAT THE BALLOON WOULD NOT INFLATE AT ALL TO DEPLOY THE STENT. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER SAME SIZE HERCULINK ELITE 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 11939704 ↗
• InjuryAug 19, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH HEAVY TORTUOSITY AND 70% STENOSIS IN THE RIGHT VERTEBRAL ARTERY. A 4.0 X 18MM HERCULINK ELITE STENT DELIVER SYSTEM (SDS) WAS BEING ADVANCED; HOWEVER, AFTER THE NON-ABBOTT GUIDEWIRE CROSSED THE VERTEBRAL ARTERY, THE SDS FAILED TO ADVANCE TO THE TARGET LESION DUE TO ANATOMY. THEREFORE, A 2.5MM BALLOON WAS USED TO DILATE THE LESION BUT THE SDS STILL FAILED TO ADVANCE. THE SDS WAS WITHDRAWN BUT ALSO MET RESISTANCE WITH ANATOMY AND THE STENT DISLODGED. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE DISLODGED STENT. THE PROCEDURE ENDED AT THIS POINT. 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 10426326 ↗
• InjuryOct 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: [THE STENT (HERCULINK 4.0X18) WAS ADVANCED TO THE RENAL ARTERY AND CAME OFF THE BALLOON. THE BALLOON DELIVERY AND WIRE WAS REMOVED. MICROSNARE INSERTED BUT UNABLE TO RETRIEVE STENT. STENT NOTED TO BE IN ILIAC ARTERY. RENAL AREA OF CONCERN WAS STENTED AND DUE TO BLOOD THINNERS THE SHEATH WAS SUTURED IN PLACE. TRANSFERRED TO PREOP WHERE RETAINED RENAL STENT WAS REMOVED IN THE OR. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RENAL STENT PLACEMENT.] ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT CONFIRMING THAT THE STENT IMPLANT WAS NOT REMOVED AND REMAINS IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9151293 ↗
• InjuryOct 3, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, LEFT PERONEAL ARTERY. THE LESION WAS PRE-DILATED WITH A 3.0 BALLOON. THE 4.0X18 MM HERCULINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY HOWEVER THE SDS FAILED TO CROSS THE TARGET LESION DUE TO RESISTANCE FELT WITH THE ANATOMY. WHILE ATTEMPTING TO ADVANCE THE SDS, THE STENT DISLODGED IN THE PATIENT ANATOMY. A SNARE DEVICE WAS USED TO REMOVE THE STENT. THE PROCEDURE WAS DISCONTINUED. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930276 ↗
• InjuryMay 5, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HERCULINK STENT DISLODGED DURING ADVANCEMENT IN THE DISTAL RADIAL ARTERY PRIOR TO TREATING THE CAROTID ARTERY AND WAS REMOVED VIA SURGICAL CUT DOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548030 ↗