Omnilink Elite 1012623-16Recalls & reported problems
Abbott Vascular Inc. · Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648179235), received between Dec 16, 2016 and Dec 23, 2016 — classified as 2 injuries.
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 Problem2
Patient problems
- Hypersensitivity/Allergic reaction2
- Numbness1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT SHE HAD A 6.0/39 MM OMNILINK ELITE STENT DEPLOYED IN HER SUBCLAVIAN ARTERY ON (B)(6) 2013. BEGINNING (B)(6) 2016, SHE IS EXPERIENCING EXCESSIVE ITCHING. THE PATIENT WAS PREVIOUSLY DETERMINED TO HAVE A NICKEL ALLERGY. SHE HAS NOT GONE BACK TO HER PHYSICIAN YET, BUT PLANS ON MAKING AN APPOINTMENT FOR DIAGNOSIS. NO TREATMENT HAS BEEN PERFORMED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 6202634 ↗InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD THREE OMNI ELITE AND ONE ABSOLUTE PRO STENTS IMPLANTED IN THE RIGHT COMMON ILIAC AND LEFT COMMON ILIAC ARTERIES ON (B)(6) 2013. APPROXIMATELY A YEAR LATER, THE PATIENT STARTED EXPERIENCING TINGLING AND SEVERE PAIN DOWN BOTH LEGS. MEDICATION HAS BEEN PRESCRIBED. THE PATIENT HAS ALWAYS BEEN SENSITIVE TO METAL; THEREFORE, AN ALLERGY KIT HAS BEEN REQUESTED BY THE ALLERGIST. ADDITIONALLY, THE PATIENT SUFFERS OF AN OCCLUSIVE PERIPHERAL DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction; Numbness; Pain
MAUDE report 6182659 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page