Omnilink Elite 1012623-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648179266), received between Oct 12, 2017 and Apr 21, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE 7.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND INFLATION WAS ATTEMPTED HOWEVER THE BALLOON DID NOT INFLATE AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED AND THE STENT WAS STILL INTACT ON THE BALLOON. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. POST PROCEDURE THE OMNILINK ELITE WAS ABLE TO BE INFLATED ON THE TABLE HOWEVER IT WAS DIFFICULT WITH A LOT OF RESISTANCE. 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 24939154 ↗
• MalfunctionApr 4, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AN OMNILINK ELITE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGE. IT WAS NOTED THAT THE STENT HAD FLARED STRUTS AND WAS MOVED/DISLOCATED ON THE DELIVERY SYSTEM BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003103 ↗
• MalfunctionApr 7, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A DISSECTION IN THE RIGHT COMMON ILIAC ARTERY. THE 7.0 X 39 MM X 80 CM OMNILINK STENT FAILED TO CROSS DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS FELT WITH THE INTRODUCER SHEATH, THE STENT STRUTS STRETCHED, AND THE STENT MOVED BUT REMAINED ON THE BALLOON. A NEW OMNILINK STENT WAS IMPLANTED WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631713 ↗
• MalfunctionFeb 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC ARTERY. THE OMNILINK ELITE PACKAGE WAS OPENED AND DEVICE PREPPED PER INSTRUCTIONS FOR USE WITHOUT ISSUES. DURING THE DEVICE ADVANCEMENT ON THE GUIDE WIRE, AND BEFORE ENTERING INTO THE SHEATH AND INTO THE ANATOMY, STENT MOVEMENT AT THE DISTAL END WAS OBSERVED/SUSPECTED. THE DEVICE HAD NOT YET ENTERED INTO THE SHEATH OR PATIENT. THERE WERE NO OTHER DEVICE ISSUE NOTED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302819 ↗
• InjuryMar 17, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT ARRIVED EMERGENTLY WITH A GROIN BLEED FROM A PREVIOUS PROCEDURE. THE PHYSICIAN CUT DOWN TO THE FEMORAL/POPLITEAL ARTERY TO BYPASS DIRECTLY. IMAGING WAS TAKEN AND THE BLEED WAS VISUALIZED AND AN 8FR SHEATH WAS INSERTED TO ATTEMPT BYPASS. A 7.0X39 MM OMNILINK ELITE STENT WAS IMPLANTED WITHOUT ISSUE. AN ABDOMINAL ANGIOGRAM WAS PERFORMED AND TIGHT STENOSIS ON THE LEFT ILIAC WAS NOTED. THE PHYSICIAN CALLED FOR ANOTHER 7.0X39 MM OMNILINK ELITE STENT AND IT WAS ADVANCED UP AND OVER THE ILIAC CREST ONLY ON A GUIDE WIRE AS THE SHEATH WAS ONLY ON THE RIGHT SIDE. ONCE THE OMNILINK REACHED THE LESION IT WAS FOUND THAT THE STENT WAS TOO SHORT. DURING REMOVAL OF THE OMNILINK ELITE SDS THE STENT DISLODGED AND WAS NOT NOTED UNTIL THE DELIVERY SYSTEM WAS PULLED OUT. THE STENT REMAINED ON THE GUIDE WIRE. A SNARE WAS USED TO BRING THE STENT TO THE RIGHT SIDE; HOWEVER, THE STENT BECAME STUCK ON THE PREVIOUSLY IMPLANTED OMNILINK ELITE STENT. A NON-ABBOTT COVERED STENT WAS THEN USED TO COVER THE ENTIRE AREA AND EMBED THE DISLODGED STENT TO THE VESSEL WALL. THERE WAS A DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9845440 ↗
• MalfunctionNov 27, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE BIFURCATION OF THE ILIAC TWO DIFFERENT OMNILINK STENT DELIVERY SYSTEMS LEAKED AT THE HUB WHEN INFLATION WAS ATTEMPTED. THE CONNECTIONS WERE CHECKED, BUT DID NOT RESOLVE THE LEAK. THE STENTS WERE NOT DEPLOYED AND WERE REMOVED WITHOUT ISSUE. A THIRD OMNILINK STENT SYSTEM WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED 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 7061148 ↗
• MalfunctionOct 12, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT COMMON ILIAC ARTERY. A 7.0 X 39 MM OMNILINK ELITE PERIPHERAL STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED, DEFLATED AND REMOVED FROM THE ANATOMY WITHOUT ISSUE. FLUOROSCOPY REVEALED THERE WAS NO STENT DEPLOYED IN THE LESION. THE ANATOMY WAS SEARCHED FOR THE BALLOON BUT IT COULD NOT BE FOUND IN THE ANATOMY. ANOTHER OMNILINK ELITE STENT WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND DEPLOYED WITHOUT ISSUE. IT IS UNKNOWN WHEN THE STENT DISLODGED; HOWEVER, IT WAS CONFIRMED IT WAS NOT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946600 ↗