Omnilink Elite 1012623-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648179259), received between Mar 26, 2018 and Jun 25, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY TORTUOUS MESENTERIC ARTERY THAT IS 80% STENOSED. THE 7.0X29MM OVER-THE-WIRE OMNI ELITE BALLOON-EXPANDABLE STENT (BES) DELIVERY SYSTEM WAS ADVANCED TO THE LESION. UPON POSITIONING THE BES FOR DEPLOYMENT, THE STENT DISLODGED. BY PARTIALLY INFLATING THE BALLOON, THE STENT WAS ABLE TO BE REPOSITIONED AND IMPLANTED AT THE INTENDED TARGET LESION. 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 25628930 ↗
• MalfunctionJan 16, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND STENOSIS. THE 7X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY WHEN THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM BALLOON WAS ADVANCED INTO THE STENT AND THE STENT WAS DEPLOYED. THE OUTCOME IS SATISFACTORY. THERE WERE NO ADVERSE PATIENT EFFECTS 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 21170765 ↗
• InjuryApr 11, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUBCLAVIAN ARTERY WITH ACCESS THRU THE RIGHT COMMON FEMORAL ARTERY (CFA). THE OMNILINK ELITE 35 7.0MMX29MMX80CM STENT DELIVERY SYSTEM (SDS) FELT NO RESISTANCE ADVANCING TO THE LESION; HOWEVER, ONCE THE DELIVERY SYSTEM REACHED THE TARGET LESION, THE STENT SIZE WAS DEEMED TOO LONG FOR THE LESION. THEREFORE, THE UNDEPLOYED STENT AND SDS WERE WITHDRAWN WITH NO RESISTANCE NOTED, BUT THE STENT DISLODGED IN THE INTERNAL ILIAC ARTERY. AN UNSUCCESSFUL RETRIEVAL WAS ATTEMPTED WITH AN UNSPECIFIED 0.014 GUIDE WIRE. THE STENT WAS THEN PUSHED DISTALLY INTO AN UNSPECIFIED COLLATERAL ARTERY BRANCH OFF THE INTERNAL ILIAC ARTERY WHERE THE VESSEL SIZE MATCHED THE STENT SIZE. THE STENT WAS NOT INFLATED. THE PROCEDURE WAS CONTINUED WITH IMPLANT OF A 6X29MM OMNILINK STENT TO TREAT THE TARGET LESION IN THE SUBCLAVIAN ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19093226 ↗
• InjuryJul 20, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT ILIAC ARTERY. THE 7.0MM X 29MM X 80CM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WAS ALSO FELT WITH THE ANATOMY DURING REMOVAL AND THE STENT DISLODGED IN THE ANATOMY. A COVERED STENT WAS SUCCESSFULLY IMPLANTED TREATING THE LESION AND AT THE SAME TIME CRUSHING THE DISLODGED STENT TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10299765 ↗
• InjuryDec 26, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ILIAC ARTERY. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE OMNILINK ELITE STENT SYSTEM AND DURING RETRACTION INTO THE SHEATH, IT WAS NOTED THAT THE STENT HAD DISLODGED. THE STENT WAS SNARED AND SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NON-ABBOTT BALLOON EXPANDABLE STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521461 ↗
• MalfunctionAug 15, 2019Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE CALCIFICATION AND NO TORTUOSITY IN THE COMMON ILIAC ARTERY. AN OMNILINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE BUT WOULD NOT CROSS A PREVIOUSLY IMPLANTED NON-ABBOTT STENT. DURING WITHDRAWAL OF THE SDS, THE PROXIMAL END STENT STRUTS BECAME FLARED AND COULD NOT BE RETRACTED BACK INTO THE 6 FR GUIDING CATHETER. BOTH DEVICES HAD TO BE WITHDRAWN AS A SINGLE UNIT. A NEW 6FR GUIDING CATHETER AND NEW OMNILINK WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897378 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APPROXIMATELY(B)(6) 2017 A 7.0 X 29 MM OMNILINK STENT WAS IMPLANTED IN THE LEFT LEG OF THE PATIENT. ALTHOUGH THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS, THE PATIENT REPORTED ON (B)(6) 2018 THAT BOTH HIS LEGS STARTED TO FEEL ITCHY A FEW DAYS AGO AND IS CURRENTLY TAKING MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 7370288 ↗