Herculink Elite 1011490-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648077920), received between Jun 8, 2018 and Apr 29, 2025 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionApr 29, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Component Missing; Off-Label Use; Improper or Incorrect Procedure or Method; Component Missing

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT VERTEBRAL ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 4.5X15 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER NO STENT WAS SEEN ON THE DELIVERY SYSTEM. THE STENT WAS NOT SEEN ON ANGIOGRAPHY. THE PHYSICIAN COULD NOT RECALL IF THE STENT WAS ON THE DELIVERY SYSTEM DURING PREP. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND 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 21931083 ↗
• InjuryAug 25, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS RIGHT VERTEBRAL ARTERY. THE PHYSICIAN CHOSE A 4.5X15MM HERCULINK ELITE BALLOON-EXPANDABLE STENT SYSTEM (BESS) AS THERE WAS NO OTHER PRODUCT OPTION AVAILABLE THAT WAS THE APPROPRIATE SIZE FOR TREATMENT BASED ON THE DIAMETER AND LENGTH OF THE VESSEL. THE BESS WAS ADVANCED OVER THE GUIDE WIRE INTO THE PATIENT; HOWEVER, THE STENT DISLODGED. CURRENTLY, THE STENT REMAINS EMBEDDED IN AN UNSPECIFIED VESSEL WITH NO FURTHER TREATMENT PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12365173 ↗
• MalfunctionOct 2, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 95% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE RIGHT RENAL ARTERY. A 4.5X15MM HERCULINK ELITE BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON FAILED TO INFLATE, AND THE STENT FAILED TO DEPLOY. THE BESS WAS REMOVED WITHOUT ISSUES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.5X15MM HERCULINK STENT. 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 10620883 ↗
• InjuryJun 8, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NARROW, MILDLY CALCIFIED, OSTIUM OF THE VERTEBRAL ARTERY, THE 4.5 X 15 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT DISLODGED FROM THE BALLOON AND MIGRATED TO THE DISTAL END OF THE BRACHIAL ARTERY. THE SDS WAS REMOVED. ANGIOGRAPHY SHOWED GOOD BLOOD FLOW, SO NO ATTEMPT WAS MADE TO RETRIEVE THE DISLODGED STENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7585054 ↗