Omnilink Elite 1012633-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648178597), received between Nov 23, 2016 and Jan 26, 2026 — classified as 4 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY. THE 10.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET. WHEN REMOVING THE SDS FROM THE SHEATH IT WAS NOTED THE STENT HAD FRACTURED WHILE STILL MOUNTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 24177328 ↗
• InjuryFeb 10, 2025Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated; Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH CALCIFICATION. THE 10X39MM OMNILINK BALLOON EXPANDED STENT (BES) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE CALCIFIED LESION. THE BALLOON WAS INFLATED, AND UPON DEPLOYMENT, THE STENT JUMPED OFF THE DELIVERY SYSTEM INTO THE AORTA. THEREFORE, A SMALL UNSPECIFIED BALLOON WAS USED TO PULL THE STENT BACK INTO THE COMMON ILIAC ARTERY. THE STENT WAS ABLE TO BE IMPLANTED PARTIALLY IN THE TARGET LESION AND PARTIALLY IN HEALTHY TISSUE. ANOTHER OMNILINK STENT WAS IMPLANTED TO COVER THE REMAINDER OF THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITION INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349693 ↗
• InjuryOct 29, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE COMMON ILIAC. A 10X39MM OTW OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED OVER A GUIDEWIRE AND THROUGH THE INTRODUCER SHEATH; HOWEVER, RESISTANCE WAS MET AND THE STENT DISLODGED INSIDE THE INTRODUCER SHEATH. THE DISLODGED STENT WAS SNARED AND REMOVED FROM THE PATIENT. ANOTHER OMNILINK BES WAS USED TO COMPLETE THE PROCEDURE. 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 20555980 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED COMMON ILIAC ARTERY. THE 10X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED. THE BALLOON INFLATED; HOWEVER, THE STENT DID NOT DEPLOY AT ALL. THE SDS WITH THE STENT STILL ON THE BALLOON WAS REMOVED FROM THE ANATOMY AND ANOTHER OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT HAD MOVED ON THE DELIVERY SYSTEM. THE ACCOUNT WAS AWARE OF THE DISLODGEMENT BUT DID NOT KNOW IF IT OCCURRED DURING ADVANCEMENT OR REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281513 ↗
• MalfunctionApr 25, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 10.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED IN THE 6FRENCH (FR) SHEATH WHEN IT GOT STUCK ABOUT 5-10CM INSIDE THE SHEATH. THE 6FR SHEATH AND SDS WERE REMOVED. THE SHEATH WAS EXCHANGED FOR A 7FR SHEATH AND ANOTHER OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809824 ↗
• InjuryNov 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 80% STENOSED LESION IN THE COMMON ILIAC ARTERY. A 10.0X39MM OMNI ELITE BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS BEING ADVANCED TO THE LESION WHEN THE STENT CAME OFF OF THE BALLOON. AN ARMADA BALLOON WAS ADVANCED TO EMBED THE STENT IN THE VESSEL WALL, JUST OUTSIDE OF THE TARGET LESION. THE PROCEDURE WAS ABORTED, AND NO OTHER STENTS WERE USED TO STENT THE LESION. THE FINAL PATIENT OUTCOME WAS SATISFACTORY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15724450 ↗
• InjuryNov 23, 2016Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE LESION WAS PRE-DILATED WITH A 9.0 MM BALLOON CATHETER SUCCESSFULLY. THE 10 X 39 MM OMNILINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DEPLOYED SUCCESSFULLY. HOWEVER, INTRAVASCULAR ULTRASOUND (IVUS) NOTED THAT THE PROXIMAL END OF THE STENT IMPLANT HAD FOLDED OVER. A BALLOON CATHETER WAS ADVANCED IN AN ATTEMPT TO MEND THE STENT, BUT THE STENT BECAME MANGLED. A CUT DOWN EMERGENCY PROCEDURE HAD TO BE PERFORMED TO EXTRACT THE MANGLED STENT FROM THE PATIENT ANATOMY. THE VESSEL WAS TREATED WITH ENDARTERECTOMY AND COMPLETED WITH A PATCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6125703 ↗