Omnilink Elite 1012623-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179273), received between Sep 9, 2022 and Apr 28, 2025 — classified as 1 injury, 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 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.

• MalfunctionApr 28, 2025Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT RADIAL ARTERY. THE 7.0X59MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WHEN THE PHYSICIAN DECIDED TO EXCHANGE THE DEVICE FOR A DIFFERENT SIZE. THE SDS WAS PULLED BACK HOWEVER RESISTANCE WAS MET WITH THE INTRODUCER SHEATH. THE STENT BECAME STUCK IN THE INTRODUCER SHEATH AND DISLODGED. THE SHEATH WAS SIMPLY REMOVED WITH THE DISLODGED STENT INSIDE. THE PROCEDURE WAS COMPLETED USING A 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21918646 ↗
• MalfunctionOct 31, 2024Difficult to Remove; Material Rupture; Activation Failure; Difficult to Remove; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON ILIAC ARTERY WITH 80% STENOSIS WITH A KISSING BALLOON TECHNIQUE. DURING DEPLOYMENT THE BALLOON OF THE 7X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) RUPTURED AT 10-11 ATMOSPHERES. THE SDS WAS REMOVED WITH THE STENT ON THE DELIVERY SYSTEM. THE SDS WAS REMOVED WITH THE SHEATH DUE TO RESISTANCE AND A NEW OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 20578542 ↗
• InjuryNov 14, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED EXTERNAL ILIAC ARTERY. THE PATIENT WAS GOING TO HAVE A RIGHT COMMON FEMORAL ENDARTERECTOMY AS WELL AND THIS WAS PERFORMED FIRST WITHOUT ISSUE. THEN A 6FR SHEATH WAS PLACED THROUGH THE PATCH ON THE IPSILATERAL SIDE AND AN .035 SUPRA CORE GUIDE WIRE WAS USED. NO PRE-DILATATION WAS PERFORMED AND THE 7X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DEPLOYMENT WAS ATTEMPTED AND THE THUMBWHEEL WAS ROLLED COMPLETELY UNTIL IT STOPPED; HOWEVER, THE STENT ONLY DEPLOYED 1 CM. THE DELIVERY SYSTEM AND STENT WERE THEN PULLED DOWN TO THE SITE OF THE ENDARTERECTOMY, AND RESISTANCE WAS NOTED WITH THE VESSEL. THE DEVICE WAS ATTEMPTED TO BE REMOVED BUT THE STENT ELONGATED SIGNIFICANTLY ACROSS THE TARGET LESION. THE ELONGATED STENT WAS CUT AND PART WAS LEFT IN SITU. NEXT, A 7X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND SIGNIFICANT RESISTANCE WAS FELT SO IT WAS DECIDED TO REMOVE THE DEVICE. THE OMNILINK ELITE SDS ONLY PARTIALLY REACHED THE LESION DUE TO RESISTANCE WITH THE ANATOMY. IN REMOVING THE DEVICE, THE STENT CAME COMPLETELY OFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132217 ↗
• MalfunctionSep 9, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED LEFT COMMON ILIAC ARTERY. THE LESION WAS PRE-DILATED WITH A 4.0X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER AND A 6.0X80 MM ARMADA 35 PTA CATHETER. THE 7X59 MM OMNNILINK ELITE STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THE STENT MOVED ON THE BALLOON DURING THE ADVANCEMENT ATTEMPT BUT IT DID NOT COME OFF THE BALLOON. THE SDS AND THE SHEATH WERE REMOVED TOGETHER TO REDUCE THE RISK OF THE STENT COMING OFF OF THE BALLOON, AND ANOTHER DILATATION WAS PERFORMED BEFORE A 7X39 MM OMNILINK STENT WAS PLACED AND DEPLOYED AT THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396622 ↗