Omnilink Elite 1012625-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179358), received between Jan 15, 2019 and Jan 2, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE WAS TO TREAT THE LEFT COMMON ILIAC ARTERY. THE 9X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER THE ILIAC BIFURCATION THERE WAS RESISTANCE AND THE STENT DISLODGED. AS THE DELIVERY SYSTEM WAS REMOVED THE STENT REMAINED IN THE RIGHT COMMON ILIAC AND WAS RETRIEVED WITH A SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23948646 ↗
• MalfunctionMay 20, 2025Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY. THE 9X59MM OTW OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION WITHOUT AN INTRODUCER SHEATH AND RESISTANCE WAS NOTED WITH THE PATIENT ANATOMY WHEN THE BES WAS ENTERING THE PATIENT. THE STENT BECAME DISLODGED OUTSIDE THE PATIENT PRIOR TO ENTERING THE PATIENT. THE OMNI ELITE BES WAS ABLE TO BE REMOVED FROM THE GUIDE WIRE. A 7FR INTRODUCER SHEATH WAS INSERTED AND ANOTHER OMNI ELITE BES WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053501 ↗
• InjurySep 7, 2021Improper or Incorrect Procedure or Method; Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY CALCIFIED LEFT COMMON ILIAC ARTERY. AN OMNILINK ELITE 9MM/59MM/80CM STENT WAS INSERTED. HOWEVER, IT WAS NOTED THE PHYSICIAN USED A 6FR SHEATH RATHER THAN A 7FR SHEATH. IT WAS NOTED THAT DUE TO THE SIZE OF THE SHEATH, SLIGHT RESISTANCE WAS FELT DURING ADVANCEMENT. IT WAS THEN OBSERVED THE STENT DISLODGED FROM THE BALLOON AND WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY. THE STENT REMAINED IN PLACE; THEREFORE, NO TREATMENT WAS PERFORMED TO FOR REMOVAL. THE 6FR SHEATH WAS REMOVED AND REPLACED WITH A 7FR SHEATH. AN ADDITIONAL OMNILINK STENT WAS INSERTED AND SUCCESSFULLY DEPLOYED AT THE INTENDED SITE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12436413 ↗
• MalfunctionJan 15, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON ILIAC ARTERY THROUGH THE RIGHT FEMORAL ARTERY. THE 9.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THERE WAS RESISTANCE NOTED WITH A PREVIOUSLY IMPLANTED UNSPECIFIED STENT FROM A PRIOR PROCEDURE. THE OMNILINK ELITE STENT DISLODGED FROM THE SDS. THE GUIDE WIRE, SDS AND DISLODGED STENT WERE PULLED INTO THE INTRODUCER SHEATH AND REMOVED TOGETHER AS A SINGLE UNIT. THE DISLODGED STENT REMAINED INSIDE THE INTRODUCER SHEATH OUTSIDE OF THE PATIENT ANATOMY AND WAS THEN ABLE TO BE REMOVED WITH HEMOSTATS. A NEW, 8.0X59MM OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A 40 MINUTE DELAY IN THE PROCEDURE, BUT THERE WAS NO EFFECT TO THE PATIENT; THEREFORE WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250941 ↗