Omnilink Elite 1012622-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179204), received between Dec 27, 2020 and Jun 20, 2024 — classified as 3 injuries, 1 malfunction.

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.

• InjuryJun 20, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6X39MM OMNILINK ELITE BALLOON EXPANDING STENT (BES) WAS BEING ADVANCED THROUGH THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BES COULD NOT COMPLETELY CROSS THE LESION; THEREFORE, THE BES WAS REMOVED FROM THE PATIENT AND WHEN THE STENT SHAFT WAS REMOVED FROM THE SHEATH THE STENT WAS NOTED TO NOT BE ON THE BALLOON. ANGIOGRAPHY FOUND THAT THE STENT WAS IN THE RIGHT ILIAC ARTERY. THEREFORE, THE BALLOON OF THE DELIVERY SYSTEM WAS RE-ADVANCED THROUGH THE STENT STRUTS AND THE STENT WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC ARTERY. AN ARMADA BALLOON WAS THEN USED TO FURTHER DILATE THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. ANOTHER STENT WAS IMPLANTED AT THE TARGET LESION TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19579683 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY. TWO OMNILINK ELITE STENTS, 6.0X39MM AND 6.0X29MM, WERE IMPLANTED. AFTER THE PROCEDURE, A SERIES OF COMPLICATIONS AROSE IN WHICH THE ARTERIES BECAME BLOCKED AND STOPPED FLOW OF BLOOD TO THE KIDNEYS. IT APPEARS THAT PLAQUE THAT HAD LOOSENED BECAME LODGED AT THE END OF THE STENTS AND BLOOD CLOTS FORMED. THE DOCTORS WENT BACK IN TO TRY AND REMOVE THE BLOCKAGE AND AFTER MANY HOURS WERE ONLY ABLE TO CLEAR ONE OF THEM, WHILE WORKING ON CLEARING ONE ARTERY THE OTHER ARTERY STILL BLOCKED RESULTED IN KIDNEY FAILURE BECAUSE IT WENT TOO LONG WITHOUT BLOOD FLOW AND THE PATIENT LOST FUNCTION OF THAT KIDNEY. THERE WAS ADDITIONAL HOSPITALIZATION DUE TO THE RENAL FAILURE. STILL WAITING TO HEAR THE RESULTS OF HOW THE ONE KIDNEY THAT WAS ABLE TO GET BLOOD FLOW IS FUNCTIONING AND IF ANY DAMAGE HAS OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18436575 ↗
• InjuryApr 8, 2022Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LESION IN DISTAL COMMON ILIAC ARTERY. THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND THE STENT WAS DEPLOYED AND WAS FULLY APPOSED. THE PHYSICIAN THEN PASSED A SHEATH THROUGH THE IMPLANTED STENT TO DO A COMPLETION RUN AND THE STENT MIGRATED INTO THE DISTAL AORTA. THE PHYSICIAN ATTEMPTED TO SNARE THE DISLODGED STENT FROM THE AORTA, BUT WAS UNSUCCESSFUL. A BALLOON CATHETER WAS ABLE TO CAPTURE THE STENT AND STENTED IT IN A NON-ABBOTT COVERED STENT. THE CONTRALATERAL SIDE DISSECTED LATER IN THE PROCEDURE AND THE PATIENT UNDERWENT FEMOROFEMORAL (FEMORAL-FEMORAL) BYPASS SURGERY; HOWEVER, IT WAS REPORTED THAT THIS WAS UNRELATED TO THE OMNILINK STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 14053171 ↗
• MalfunctionDec 27, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THE OMINILINK STENT DELIVERY SYSTEM WAS PREPPED BEFORE REMOVAL OF THE PROTECTIVE SHEATH, AND THE STENT CAME OFF THE BALLOON. THE DEVICE WAS NOT USED, AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11074128 ↗