Omnilink Elite 1012629-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648179532), received between Oct 27, 2017 and Aug 20, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Failure to Advance; Device Dislodged or Dislocated

  It was reported that the procedure was to treat an internal iliac artery lesion with 90% stenosis. A 7x39 mm Omnilink Elite stent delivery system (SDS) was advanced; however, it failed to cross the lesion due to the anatomy. The 6x39 mm Omnilink Elite SDS was advanced and it also failed to cross the lesion. The stent then became dislodged from the SDS and moved into the aorta. A new 10mm Omnilink stent was implanted to embed the dislodged stent in the iliac artery and complete the procedure. There was a clinically significant delay in the procedure. No additional information was provided.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50358877 ↗
• MalfunctionMay 16, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT CORNER OF THE 6.0X39MM OMNILINK ELITE STENT PACKAGING CONTAINING THE DEVICE WAS FOUND TO BE UNSEALED UPON REMOVAL FROM THE OUTER PACKAGING AND NO LONGER STERILE. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336451 ↗
• InjuryNov 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL ANASTOMOSIS IN THE RIGHT LEG NEAR THE POPLITEAL ARTERY THAT HAD HEAVY CLOTTING OF THE VEIN GRAFT. A 6.0X39MM OMNILINK ELITE WAS ADVANCED AND WAS ATTEMPTING TO BE POSITION AS MULTIPLE UNSPECIFIED STENTS WERE ALSO USED TO TREAT THE HEAVY CLOTTING. WHEN PULLING BACK THE DEVICE FOR REMOVAL NEGATIVE WAS PULLED AND THE STENT DISLODGED. THE STENT WAS REMOVED VIA SNARE WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809831 ↗
• InjuryJul 16, 2020Failure to Advance; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Failure to Advance; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MESENTERIC ARTERY. AFTER INTRODUCING THE 6.0X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM INTO THE VESSEL, RESISTANCE WAS NOTED AND THE SHAFT BECAME KINKED. WHILE TRYING TO REPOSITION THE DELIVERY SYSTEM DURING A GUIDING CATHETER EXCHANGE, THE STENT DISLODGED FROM THE STENT BALLOON. THE PHYSICIAN WAS ABLE TO MOVE THE STENT WITH THE DELIVERY SYSTEM UNTIL IT REACHED THE ILIAC ARTERY AND THE STENT WAS IMPLANTED IN HEALTHY TISSUE. REPORTEDLY, THE PROCEDURE WAS RESCHEDULED TO ANOTHER DAY AND THE TARGET LESION WAS SUCCESSFULLY TREATED WITH ANOTHER SAME SIZE OMNILINK ELITE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10284072 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PERIPHERAL STENTING PROCEDURE, WITH IMPLANTATION OF A 6.0 X 39 MM OMNILINK ELITE STENT. PER PATIENT, THE STENT WAS IMPLANTED IN HER LOWER INTESTINE. SHE NOW REPORTS FEELING PAIN ON THE LEFT SIDE, JUST ABOVE HER STOMACH. SHE REPORTS THAT THE PAIN IS SOMETIMES A DULL ACHE AND SOMETIMES A SHARP PAIN, AND THAT HER ¿INSIDES FEEL RAW¿. SHE REPORTS THAT FREQUENTLY WHEN SHE FEELS THE PAIN, SHE HAS A BOUT OF DIARRHEA. THE PATIENT HAS NOT BEEN PRESCRIBED ANY MEDICATIONS AS TREATMENT OF THE PAIN AND HAS NOT HAD ANY ADDITIONAL INTERVENTION. SHE REPORTS THAT SHE HAS A NICKEL ALLERGY AND HAS CONCERNS THAT SHE MAY BE ALLERGIC TO THE IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9593877 ↗
• InjuryMay 25, 2018Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT ILIAC ARTERY. THE 6.0/39 MM/135 CM OTW OMNILINK STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUE IN THE LESION, AFTER WHICH AN ATHERECTOMY DEVICE WAS ADVANCED THROUGH THE DEPLOYED STENT IN THE ILIAC TO PERFORM ATHERECTOMY; HOWEVER, THE BURR ON THE ATHERECTOMY DEVICE BROKE OFF LEAVING THE WIRE ON THE DEVICE FREE TO MOVE WHICH RESULTED IN THE WIRE BECOMING ENTANGLED IN THE DEPLOYED STENT AND UPON REMOVAL OF THE ATHERECTOMY DEVICE, IT PULLED THE DEPLOYED STENT, BUNCHED UP, INTO THE COMMON FEMORAL ARTERY. THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF THE BUNCHED UP STENT IMPLANT AND THE ATHERECTOMY DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545277 ↗
• MalfunctionMay 24, 2018Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED, ILIAC ARTERY. DURING STENT DEPLOYMENT, THE 6.0 X 39 MM OMNILINK ELITE BALLOON RUPTURED AT 16 ATMOSPHERE (ATM). NOTABLY, THE AREA NEAR THE HUB LEAKED CONTRAST. THE DELIVERY SYSTEM WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. POST DILATATION WAS PERFORMED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543337 ↗
• MalfunctionOct 27, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MODERATELY CALCIFIED, HEAVILY TORTUOUS LEFT SUBCLAVIAN ARTERY INTERVENTION, THE 6.0 X 39 OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THROUGH A PREVIOUSLY IMPLANTED STENT AND GET TO THE LESION. THE SDS WAS REMOVED FROM AND RE-INSERTED INTO THE ANATOMY THREE TIMES. AFTER THE LAST REMOVAL AND RE-INSERTION, THE STENT WAS NO LONGER ON THE DELIVERY SYSTEM AND COULD NOT BE LOCATED, BUT IT WAS SUSPECTED TO HAVE DISLODGED INSIDE THE 7 FRENCH SHEATH. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985660 ↗