Omnilink Elite 1012629-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648179525), received between Mar 2, 2018 and Sep 24, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2025Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TYPE 2 AORTIC DISSECTION EXTENDING INTO THE LEFT RENAL ARTERY, EXTENDING INTO THE SUPERIOR MESENTERIC ARTERY (SMA) AND ILIAC ARTERIES. A 6.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER FAILED TO ADVANCE ACROSS THE SMA DUE TO THE DISSECTION. DURING REMOVAL RESISTANCE WITH FELT WITH THE NON-ABBOTT SHEATH AND THE STENT DISLODGED JUST ABOVE THE NON-ABBOTT SHEATH IN THE AORTA. THE STENT WAS REMOVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137201 ↗
• MalfunctionAug 3, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND A 6.0X29MM OMNILINK STENT WAS ATTEMPTED TO BE ADVANCE THROUGH THE STENT; HOWEVER, FELT RESISTANCE WITH THE PREVIOUSLY IMPLANTED STENT AND THE PHYSICIAN DECIDED TO REMOVE THE STENT. ONCE REMOVED IT WAS NOTED THAT THE STENT WAS STILL ON THE DELIVERY CATHETER; HOWEVER, NOTED TO BE LOOSE. THEREFORE, THE UNSPECIFIED SHEATH WAS REPOSITIONED AND A NEW 6X39MM OMNILINK STENT CROSSED WITHOUT ISSUE AND WAS SUCCESSFULLY IMPLANTED. THERE WAS 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 17452249 ↗
• MalfunctionApr 19, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 95% STENOSED LESION IN THE SUBCLAVIAN ARTERY. A 6.0X29MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. DURING WITHDRAW OF THE BES, THE STENT BECAME CAUGHT ON THE 6F SHEATH, AND THE STENT AND THE SHEATH WERE REMOVED AS A SINGLE UNIT WITHOUT ISSUE. A SAME SIZE NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770488 ↗
• MalfunctionDec 3, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 6.0X29MM OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS BEING ADVANCED; HOWEVER, FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE BESS WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT RESISTANCE. ONCE THE BESS WAS OUTSIDE THE PATIENT ANATOMY IT WAS NOTED THAT THE STENT WAS MISSING. THE STENT WAS LOCATED INSIDE THE DISTAL TIP OF THE 6F SHEATH. THE SHEATH WAS REMOVED WITH THE STENT IN IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 6F SHEATH AND A 7X27MM UNSPECIFIED NON-ABBOTT STENT. 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 9405597 ↗
• MalfunctionMar 2, 2018Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED AND HEAVILY CALCIFIED LESION IN THE ILIAC ARTERY. IT WAS NOTICED THAT THE STENT OF A 6X29MM OMNI ELITE UNRAVELED (FLARED) WHILE ATTEMPTING TO INSERT IT INTO THE SHEATH. IT WAS CONFIRMED THAT THE STENT DID NOT DISLODGE; HOWEVER, THE SPECIFIC STENT DAMAGE COULD NOT BE CONFIRMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OMNI ELITE STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS FOUND THAT THE STENT WAS STRETCHED OUT AND DISLOCATED ON THE BALLOON YET STATIONARY, WITH THE PROXIMAL END OF STENT AT 12.5MM PROXIMAL TO DISTAL BALLOON MARKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7311214 ↗