Omnilink Elite 1012622-16Recalls & reported problems
Abbott Vascular Inc. · Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 16 mm x 80 cm Over-The-Wire · Class 3 · Implant
All models of Omnilink Elite (42)
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 08717648179174), received between Jun 13, 2023 and Jun 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2023Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
SUBSEQUENT TO THE INITIALLY FILED REPORT, THE ACCOUNT STATED THAT THE BES WAS INTENDED FOR USE IN THE RENAL ARTERY; HOWEVER, WAS WITHDRAWN PRIOR DEPLOYMENT. RETURNED DEVICE ANALYSIS IDENTIFIED, THE STENT DELIVERY SYSTEM (SDS) WAS NOT INCLUDED WITH THE REST OF THE DEVICE; HOWEVER, THE ACCOUNT STATED THAT THE SDS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17120357 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 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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