Omnilink Elite 1012629-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648179549), received between Sep 9, 2016 and Jan 6, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM, THE STENT FELL OFF OF THE DELIVERY SYSTEM WHILE ON THE BACK TABLE. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. TWO OTHER STENTS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977778 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, THE 6X59MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS SIMPLY REMOVED FROM THE HOOP TRAY WHEN IT WAS NOTED THAT THE STENT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER OMNILINK BESS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079562 ↗
• MalfunctionMar 19, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING AN ILIAC ARTERY, HEAVILY CALCIFIED LESION. A 6FR SHEATH WAS PLACED LEFT PEDAL ACCESS AND A 6.0 OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) ADVANCED. THE SDS HAD FAILED TO CROSS THE HEAVILY CALCIFIED ILIAC LESIONS DUE TO ANATOMY. DURING SDS REMOVAL, DIFFICULTY WAS NOTED WITH THE SDS WITHIN THE SHEATH. THE STENT DISLODGED IN THE SHEATH. THE SHEATH AND SDS WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT WITHOUT FURTHER ISSUES. NOTHING WAS LEFT INSIDE THE ANATOMY BESIDES THE GUIDE WIRE. ANOTHER SHEATH WAS PLACED AND PROCEDURE CONTINUED USING ANOTHER OMNILINK ELITE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433960 ↗
• InjuryMay 1, 2017Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO LESION IN THE NON-TORTUOUS, BUT TIGHT, PROXIMAL LEFT COMMON ILIAC ARTERY. A 6.0MM X 59MM X 135CM OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM WAS ADVANCED OVER A 0.035 NON-ABBOTT GUIDE WIRE AND TO THE TARGET LESION WITHOUT RESISTANCE. WHEN VERIFYING STENT POSITION UNDER FLUOROSCOPY, IT WAS NOTED THAT THE OMNILINK ELITE SYSTEM HAD INADVERTENTLY BEEN ADVANCED PAST THE TARGET LESION INTO THE DISTAL LEFT COMMON ILIAC. WHEN PULLING THE OMNILINK ELITE SYSTEM BACK TOWARD THE PROXIMAL ILIAC TARGET LESION, RESISTANCE WAS FELT AGAINST THE LESION CALCIFICATION, BUT NO FORCE WAS APPLIED, AND THE STENT DISLODGED IN THE DISTAL ILIAC. THE OMNILINK ELITE DELIVERY SYSTEM WAS WITHDRAWN FROM THE ANATOMY WITHOUT DIFFICULTY. UNSPECIFIED 3.0MM THEN 4.0MM BALLOONS WERE EACH ADVANCED INTO THE UNEXPANDED OMNILINK ELITE STENT, AND THE BALLOONS WERE EACH INFLATED, GRADUALLY PULLING THE STENT BACK INTO THE TARGET LESION. AN UNSPECIFIED 6.0MM BALLOON WAS THEN ADVANCED AND THE OMNILINK ELITE WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6534423 ↗
• InjurySep 9, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE THREE OMNILINK ELITE STENTS WERE IMPLANTED FROM THE LEFT ILIAC TO THE RIGHT ILIAC ARTERY ON (B)(6) 2016. AFTER THE PROCEDURE, THE PATIENT HAD BACK PAIN. SEVERAL WEEKS LATER, THE PATIENT HAD SWELLING IN HER LEGS. THE DOCTOR PRESCRIBED HER PREDNISONE FOR THE BACK PAIN, BUT IT HAS NOT HELPED. A WEEK AFTER THAT, SHE BEGAN HAVING LEFT LEG PAIN TO THE POINT WHERE SHE IS UNABLE TO STAND ON THE LEFT LEG. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 5940898 ↗