Omnilink Elite 1012626-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648179372), received between Oct 5, 2018 and Oct 30, 2019 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ILIAC ARTERY THAT WAS DISEASED. THE OMNILINK BALLOON EXPANDABLE STENT WAS BEING ADVANCED TO THE LESION, WITH NO RESISTANCE MET; HOWEVER, IT WAS NOTED THAT THE STENT SEEMED TO HAVE MOVED/COMING OFF FROM THE BALLOON. IT WAS DECIDED TO REMOVE THE SHEATH AND THE DEVICE ALTOGETHER, THEN THE STENT BECAME DISLODGED IN THE LEFT COMMON FEMORAL ARTERY. THE HOSPITAL DID NOT HAVE THE TOOLS FOR STENT REMOVAL AND THEREFORE THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL WHERE THE DISLODGED STENT WAS REMOVED VIA SURGICAL PROCEDURE. THE PATIENT IS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258352 ↗
• MalfunctionOct 5, 2018Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY TORTUOUS SUBCLAVIAN VEIN THAT WAS 90% STENOSED. A GLIDESHEATH WAS INSERTED IN THE LEFT BRACHIAL ARTERY AND A .018 NON-ABBOTT GUIDE WIRE CROSSED THE LESION. THEN THE GUIDE WIRE WAS REPLACED WITH A .035 NON-ABBOTT GUIDE WIRE, AND PRE-DILATATION WAS PERFORMED WITH A 9.0 X 20 MM NON-ABBOTT BALLOON DILATATION CATHETER. A 10 X 29 MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT WAS IMPLANTED; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE DEVICE FROM THE INTRODUCER SHEATH. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITH THE SHEATH AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938786 ↗