Herculink Elite 1011496-12Recalls & reported problems
Abbott Vascular Inc. · RX Herculink Elite Renal and Biliary Stent System 5.5 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
- 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 08717648078095), received between Aug 12, 2021 and Jan 16, 2024 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Difficult to Advance1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 5.5X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) HAD DIFFICULTY BEING ADVANCED THROUGH THE INTRODUCER SHEATH AFTER BEING FLUSHED. IT WAS THEN NOTED THAT THE STENT HAD MOVED ON THE DELIVERY SYSTEM SO THE DEVICE WAS REPLACED WITH A NEW HERCULINK ELITE SDS 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 18521587 ↗InjuryAug 12, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE LEFT RENAL ARTERY. THE LESION WAS PRE-DILATED SUCCESSFULLY. A 5.5 X 12 MM HERCULINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE HEAVILY CALCIFIED LESION AND DURING THE ATTEMPT THE STENT DISLODGED. THE DISLODGED STENT REMAINED ON THE GUIDE WIRE. THE SDS WAS REMOVED WITHOUT ISSUE. A SNARE DEVICE WAS USED TO HELP RETRIEVE THE DISLODGED STENT. A NEW HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12313355 ↗
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