Omnilink Elite 1012633-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648178603), received between Feb 22, 2018 and Nov 25, 2024 — classified as 1 injury, 3 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 16, 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.

• InjuryNov 25, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY TORTUOUS, HEAVILY CALCIFIED COMMON ILIAC ARTERY. WHEN ADVANCING THE 10X59MM OMNILINK ELITE STENT DELIVERY SYSTEM RESISTANCE WAS FELT WITH ANATOMY AND THE STENT DISLODGED. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS ADVANCED AND INFLATED IN THE ATTEMPT TO BRING BACK THE STENT; HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE STENT WAS HELD IN PLACE WITH DEVICE AND ANOTHER 9.0X59MM OMILINK ELITE STENT WAS ATTEMPTED TO BE ADVANCED TO TREAT THE LESION; HOWEVER, MET RESISTANCE WITH ANATOMY AND DISLODGED. THE DISLODGED STENT WAS ATTEMPTED TO BE SNARED BUT THE SNARE DEVICE BECAME STUCK WITH ANATOMY AND THE STENT. IT WAS NOTED THAT THE STENTS HAD OCCLUDED IN THE PROXIMAL EXTERNAL ILIAC ARTERY BLOCKING MOST OF THE BLOOD FLOW THROUGH THE ILIAC. THE SNARE DEVICE COULD NOT BE PULLED BACK. THE SNARE DEVICE WAS BROKEN ON PURPOSE AND THE STUCK PORTION ALONG WITH BOTH STENTS WERE CRUSHED INTO THE VESSEL WALL WITH A NON-ABBOTT STENT OVER THEM. BLOOD FLOW WAS RESTORED WHEN THE STENTS WERE CRUSHED AND CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 20774720 ↗
• MalfunctionJan 11, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 10.00X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) THE WIRE LUMEN WAS FLUSHED; HOWEVER, NEGATIVE PRESSURE WAS NOT HELD. THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON ILIAC ARTERY. WHILE BACKLOADING THE DEVICE ONTO THE GUIDEWIRE, OUTSIDE THE PATIENT ANATOMY, AND BEFORE ENTERING THE ROTATING HEMOSTATIC VALVE (RHV), THE STENT BECAME PARTIALLY DISLODGED FROM THE BALLOON AND WAS NOT USED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE OMNILINK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142824 ↗
• MalfunctionMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT ILIAC ARTERY. A 10X59MM OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUES. THE BESS WAS ADVANCED ON AN UNKNOWN GUIDE WIRE; HOWEVER, IT WAS NOTED THAT THE STENT WAS LOOSE ON THE BESS BEFORE IT WAS ADVANCED THROUGH THE INTRODUCER SHEATH. THE BESS WAS SIMPLY REMOVED FROM THE GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 10X59MM OTW OMNI ELITE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593090 ↗
• MalfunctionFeb 22, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE LOADING AN OMNI ELITE STENT DELIVERY SYSTEM ONTO THE GUIDE WIRE, THE DISTAL END OF THE DEVICE WAS HANDLED AND STENT WAS POSSIBLY PULLED; HOWEVER, THIS COULD NOT BE CONFIRMED. JUST AFTER LOADING AND BEFORE ADVANCING THE DEVICE INTO THE ANATOMY, THE STENT DISLODGED. THE DEVICE WAS SET ASIDE AND NOT USED FURTHER. ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7289929 ↗