Herculink Elite 1011499-12Recalls & reported problems
Abbott Vascular Inc. · RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 12 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648078187), received between Jul 16, 2020 and Jul 16, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intimal Dissection1
- Pain1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT A HERCULINK STENT WAS IMPLANTED IN THE CALCIFIED RIGHT RENAL ARTERY WITHOUT ISSUE; HOWEVER, A DISSECTION WAS NOTED. NO TREATMENT WAS PROVIDED. WHILE OBSERVING THE PATIENT POST PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND ANGIOGRAPHY NOTED FREE FLOW OF CONTRAST. A 5.5X15MM BALLOON WAS INFLATED TO TAMPONADE THE BLEED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. DETAILS ARE LISTED IN THE ARTICLE, TITLED ¿COVERED STENTS IN RENAL ARTERY INTERVENTIONS¿.
Patient problems: Intimal Dissection; Pain; Perforation
MAUDE report 10286900 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page