Herculink Elite 1011490-18Recalls & reported problems
Abbott Vascular Inc. · RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 18 mm x 135 cm · Class 3 · Implant
All models of Herculink Elite (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648077937), received between Jan 17, 2021 and Sep 2, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (1 report).
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
Device problems
- Activation Failure1
- Device Dislodged or Dislocated1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2021Activation Failure; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE RIGHT RENAL ARTERY. A 4.5X18MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO THE LESION, BUT THE BALLOON FAILED TO INFLATE AFTER SEVERAL ATTEMPTS. THE BESS WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.5X18MM HERCULINK ELITE STENT. 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 12417902 ↗InjuryJan 17, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT VERTEBRAL ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 80% STENOSED. THE RX HERCULINK ELITE STENT SYSTEM WAS ADVANCED TO THE LESION, BUT THE STENT WAS NOT THERE AND WAS NOT ABLE TO BE FOUND IN THE PATIENT. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SEQUELA. ANOTHER STENT OF THE SAME TYPE WAS ACCURATELY POSITIONED AND DEPLOYED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 11183335 ↗
Other STENT, RENAL devices
- Herculink Elite 1011487-15Abbott Vascular Inc. · STENT, RENAL27 reports
- Express® SD Renal/Biliary H74937912618150Boston Scientific Corporation · STENT, RENAL27 reports
- Herculink Elite 1011487-12Abbott Vascular Inc. · STENT, RENAL24 reports
- Herculink Elite 1011493-18Abbott Vascular Inc. · STENT, RENAL1 death16 reports
- Herculink Elite 1011499-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011487-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011499-15Abbott Vascular Inc. · STENT, RENAL12 reports
- Herculink Elite 1011493-12Abbott Vascular Inc. · STENT, RENAL11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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