Omnilink Elite 1012622-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179211), received between Jul 6, 2017 and Jan 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2024Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY AND ILIAC WITH 100% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A BALLOON. THE 6.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO A 6FRENCH (F) SHEATH AND ADVANCED INTO THE ANATOMY, HOWEVER, THE DEVICE COULD NOT CROSS TO THE TARGET LESION AND WAS REMOVED FROM THE ANATOMY. ANOTHER PRE-DILATATION WAS PERFORMED AND THIS TIME MORE AGGRESSIVELY AND THE SAME OMNILINK ELITE SDS WAS ADVANCED BUT STILL FAILED TO CROSS THE LESION. UPON REMOVAL, THE DEVICE WAS BEING PULLED BACK INTO THE 6F SHEATH WITH RESISTANCE AND WAS BEING PULLED OUT OF THE ANATOMY WITH RESISTANCE AS WELL WHEN THE STENT FULLY DETACHED FROM THE BALLOON INTO THE EXTERNAL ILIAC, STILL UNEXPANDED. A SNARE WAS ATTEMPTED, BUT THE STENT COULD NOT BE REMOVED AND STARTED TO ELONGATE FROM THE COMMON FEMORAL TO THE EXTERNAL ILIAC, AS IT SEEMED TO BE STUCK IN THE CALCIFICATION. THEREFORE, THEY WENT IN WITH A NON-ABBOTT COVERED STENT AND EMBEDDED THE STENT WHERE IT REMAINED, FROM THE COMMON FEMORAL TO THE EXTERNAL ILIAC. THE PROCEDURE WAS ABORTED AT THAT POINT. THERE WAS AN APPROXIMATE 3

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18567147 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT HAD UNDERGONE PREVIOUS INTERVENTION DURING WHICH TWO 6.0MM/59MM OMNILINK ELITE VASCULAR STENTS WERE DEPLOYED IN THE COMMON ILIAC WITHOUT ISSUE. ON (B)(6) 2017, THE PATIENT UNDERWENT ANGIOGRAPHY DUE TO COMPLAINTS OF PAIN IN THE STOMACH AREA. ANGIOGRAPHY REVEALED THROMBOSIS IN BOTH OMNILINK STENTS. A PERCUTANEOUS INTERVENTION WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE THROMBOSIS, WHICH WAS FOLLOWED BY STENTING ON (B)(6)2017 TO PLACE NON-ABBOTT STENTS INSIDE THE OMNILINK STENTS. THE PATIENT EXPERIENCED A HEMATOMA FROM THE THROMBOLYSIS, BUT OTHERWISE IS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Pain; Thrombosis

  MAUDE report 7014201 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT HAD UNDERGONE PREVIOUS INTERVENTION DURING WHICH TWO 6.0 MM/59 MM OMNILINK ELITE VASCULAR STENTS WERE DEPLOYED IN THE COMMON ILIAC WITHOUT ISSUE. ON (B)(6) 2017, THE PATIENT UNDERWENT ANGIOGRAPHY DUE TO COMPLAINTS OF PAIN IN THE STOMACH AREA. ANGIOGRAPHY REVEALED THROMBOSIS IN BOTH OMNILINK STENTS. THROMBOLYSIS WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE THROMBOSIS; HOWEVER, SOME THROMBOSIS REMAINED. ON (B)(6) 2017, TWO NON-ABBOTT STENTS WERE IMPLANTED INSIDE THE OMNILINK STENTS FOR TREATMENT. THE PATIENT EXPERIENCED A HEMATOMA FROM THE THROMBOLYSIS, BUT OTHERWISE IS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Pain; Thrombosis

  MAUDE report 7014183 ↗
• InjuryJul 6, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE MILDLY CALCIFIED TARGET LESION IN THE RIGHT ILIAC ARTERY THROUGH THE LEFT ACCESS SITE. THE SDS WAS REMOVED AND THE LESION WAS PREDILATED. THE SDS WAS RE-INSERTED, BUT WAS STILL UNABLE TO CROSS THE LESION. DURING WITHDRAWAL OF THE SDS, THE STENT BEGAN TO DISLODGE FROM THE SDS SO THE SDS WAS RE-ADVANCED AND THE STENT WAS DEPLOYED PROXIMAL TO THE INTENDED LESION TO KEEP THE STENT FROM TRAVELING AWAY FROM ITS CURRENT LOCATION. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6690167 ↗