Omnilink Elite 1012630-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648178467), received between Nov 17, 2016 and May 29, 2025 — classified as 4 injuries, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Entrapment of Device; Material Rupture; Difficult to Advance; Device Dislodged or Dislocated; Activation Failure; Entrapment of Device; Material Rupture; Difficult to Advance; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) VIA A PEDAL APPROACH. THE 7X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) BECAME STUCK IN THE CALCIUM OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DURING ADVANCEMENT AND THE DEVICE ALSO COULD NOT BE PULLED BACK. IT WAS ATTEMPTED TO PULL THE DEVICE BACK INTO THE SHEATH BUT IT WOULD NOT COME OUT. THE BALLOON WAS INFLATED TWICE TO NOMINAL PRESSURE AND IT WAS THOUGHT THAT THE BALLOON OF THE DELIVERY SYSTEM HAD RUPTURED AND KEPT THE STENT FROM DEPLOYING. THE STENT WAS NOT LINED UP WITH THE BALLOON MARKERS. ADDITIONAL BALLOONS WERE ADVANCED TO ATTEMPT TO DEPLOY THE STENT BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED HOSPITALS SO A VASCULAR SURGEON COULD REMOVE THE DEVICE VIA SURGICAL CUT DOWN. THE PATIENT IS DOING OK AFTER THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107996 ↗
• InjuryApr 18, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A SUBCLAVIAN VESSEL THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 7.0X29MM OMNILINK ELITE BALLOON-EXPANDABLE STENT, RESISTANCE WAS MET AND FAILED TO CROSS. WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM, THE STENT DISLODGED AND WAS CRUSHED IN HEALTHY TISSUE. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21867741 ↗
• MalfunctionMay 11, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERIOR MESENTERIC ARTERY. THE 7X29MM OTW OMNI ELITE STENT WAS ADVANCED TO THE LESION, BUT DURING DEPLOYMENT, THE STENT JUMPED DISTALLY AND ONLY PARTIALLY COVERED THE LESION. ANOTHER OMNILINK STENT WAS IMPLANTED TO FULLY COVER THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366194 ↗
• MalfunctionMar 20, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE ILIAC ARTERY. THE 7.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. DURING RETRACTION, THE STENT STRUTS BECAME FLARED AND INTERACTED WITH THE 6FR SHEATH, CAUSING RESISTANCE. THE SDS WAS ABLE TO BE RETRACTED INTO THE SHEATH AND REMOVED FROM THE ANATOMY. AN ABSOLUTE PRO STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863176 ↗
• InjuryNov 4, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 7.0X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE TORTUOUS ANATOMY DURING ADVANCEMENT TO THE SUPERIOR MESENTERIC ARTERY (SMA). THE SMA WAS ACCESSED VIA THE RIGHT GROIN. DUE TO THE TORTUOSITY, THE STENT DISLODGED FROM THE SDS AND REMAINED IN THE AORTA. A SNARE WAS INSERTED THROUGH THE LEFT GROIN AND THE STENT WAS REMOVED FROM THE AORTA WITHOUT DIFFICULTY. THE SMA WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272708 ↗
• InjuryNov 17, 2016Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 5.5X150 SUPERA STENT HAD BECOME TWISTED, TELESCOPED FROM MOVEMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WHEN THE PATIENT WAS WALKING AND THE PATIENT HAD LEG PAIN. THE 7.0 X 29 OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INSERTED TO HELP STRAIGHTEN OUT THE VESSEL TO ALLOW ANOTHER SUPERA TO BE DEPLOYED IN THE SFA, BUT THE SDS INTERACTED WITH THE OCCLUDED SUPERA STENT. THE SDS WAS REMOVED AND THE SUPERA WAS BALLOON DILATED. THE OMNILINK SDS WAS RE-INSERTED, BUT THE OMNILINK STENT DISLODGED FROM THE SDS BALLOON. THE SDS WAS USED TO PUSH THE DISLODGED STENT AS FAR DOWN AS THEY COULD GET IT AND THE OMNILINK STENT WAS DEPLOYED WITH A 4.0X100 NON-ABBOTT BALLOON. THE OMNILINK SDS WAS RE-INSERTED AND INFLATED FOR POST DILATATION. ANOTHER SUPERA WAS IMPLANTED, AS PLANNED, TO TREAT THE OCCLUDED 5.5X150 SUPERA. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111335 ↗