Omnilink Elite 1012624-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648179280), received between Apr 13, 2018 and Dec 23, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjuryDec 23, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 8.0X19MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE DURING THE ATTEMPT TO CROSS THE LESION THE STENT DISLODGED. THE SDS WAS WITHDRAWN AND A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED USING A SAME SIZE DEVICE. 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 23878641 ↗
• MalfunctionNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 8X19MM OMNILINK ELITE DELIVERY SYSTEM WAS REMOVED FROM PACKAGING, THE STENT WAS OBSERVED TO BE DISLODGED. ANOTHER OMNILINK ELITE WAS USED TO SUCCESSFULLY 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 23478071 ↗
• MalfunctionDec 13, 2022Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ILIAC ARTERY. THE 8.0X19MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ACROSS THE LESION AND BALLOONED, HOWEVER, IT WAS NOTED THAT THE STENT COULD NOT BE FOUND AND WAS NOT ON THE BALLOON. UPON FLUOROSCOPY, IT WAS CONFIRMED THE STENT WAS NOT IN THE PATIENT'S ANATOMY. THE STENT WAS FOUND IN THE STYLET AT THE BACK OF THE TABLE. THERE WAS NO RESISTANCE REMOVING THE SDS FROM THE DISPENSER COIL AND THERE WAS NO RESISTANCE DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH. THE SDS WAS NOT PREPARED BEFORE OR AFTER THE SHEATH/STYLET REMOVAL. FORCE WAS NOT APPLIED DURING REMOVAL OF THE SHEATH/STYLET. THERE WAS NO MANIPULATION/HANDLING OF THE STENT IMPLANT AT ANY POINT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969649 ↗
• InjuryAug 23, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 70% STENOSED AND MODERATELY CALCIFIED LESION IN THE SUPERIOR MESENTERIC ARTERY. AN 8.0X19MM OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE BESS WAS BEING REMOVED BUT RESISTANCE WITH THE GUIDE CATHETER WAS FELT AND IT WAS NOTED THAT THE STENT DISLODGED. THE DISLODGED STENT MIGRATED TO AN UNSPECIFIED LOCATION. A SNARE WAS USED TO RETRIEVE THE STENT, BUT THEN THE SNARE COULD NOT BE REMOVED THROUGH THE SHEATH; THEREFORE, THE PATIENT WAS SENT TO VASCULAR SURGERY. THE STENT AND SNARE WERE SUCCESSFULLY REMOVED VIA SURGERY. THERE WAS A CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355919 ↗
• MalfunctionJun 17, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUBCLAVIAN ARTERY. AN 8.0X19MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED THROUGH AN UNSPECIFIED STENT IN AN ATTEMPT TO TREAT A LESION DISTALLY; HOWEVER, MET RESISTANCE WITH THE UNSPECIFIED IMPLANTED STENT AND BECAME CRUMPLED. THE STENT DISLODGED BUT REMAINED ON THE SHAFT AND WAS SIMPLY WITHDRAWN. THERE WAS NO ADVERSE PATIENT EFFECTS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020399 ↗
• MalfunctionMar 13, 2020Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LEFT PULMONARY ARTERY. AN 8.0X19MM OMNILINK ELITE STENT WAS INFLATED AT 14 ATMOSPHERES AND DEPLOYED IN THE LESION. THEN A NON-ABBOTT CATHETER WAS ADVANCED OVER THE STIFF GUIDE WIRE IN ORDER TO MEASURE PRESSURE DIFFERENCE OF THE DISTAL PART OF THE DEPLOYED STENT; HOWEVER, THE CATHETER DID NOT ADVANCE THROUGH THE OMNILINK STENT. THEREFORE, THE NON-ABBOTT CATHETER WAS REPLACED WITH ANOTHER NON-ABBOTT CATHETER; HOWEVER, THAT CATHETER DID NOT ADVANCE EITHER. AN ATTEMPT WAS MADE TO REMOVE THE STIFF GUIDE WIRE; HOWEVER, THE STIFF GUIDE WIRE COULD NOT BE REMOVED AND BECAME UNRAVELED. ON THE SAME DAY, SURGICAL TREATMENT WAS PERFORMED TO REMOVE THE GUIDE WIRE. PER THE PHYSICIAN, IT IS POSSIBLE THE OMNILINK ELITE STENT COULD NOT BE FULLY EXPANDED DUE TO THE ANATOMY AND THE GUIDE WIRE BECAME TRAPPED IN THE STENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831940 ↗
• InjurySep 19, 2019Off-Label Use; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO RE-STENOSIS IN THE PREVIOUSLY IMPLANTED OMNILINK STENT. HOWEVER, DUE TO THE INCONSISTENCIES OF THE REPORTED INFORMATION, THE RE-STENOSIS MAY HAVE OCCURRED. THE 8X19MM OMNILINK ELITE STENT MAY NOT HAVE FAILED TO CROSS DUE THE IMPLANTED STENT, BUT DUE TO THE INCONSISTENCIES OF THE REPORTED INFORMATION, THE IMPLANTED STENT MAY HAVE CAUSED THE FAILURE TO CROSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086356 ↗
• InjuryApr 13, 2018Unstable; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TARGET LESION IN THE MODERATELY CALCIFIED LEFT SUBCLAVIAN ARTERY. THE 8.0 X 19 MM OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DURING POSITIONING, THE STENT STARTED TO COME OFF THE DELIVERY SYSTEM BALLOON. AS THE STENT WAS STILL PARTIALLY ON THE DELIVERY SYSTEM BALLOON, THE PHYSICIAN WAS ABLE TO PULL THE DELIVERY SYSTEM BACK A BIT AND GET THE STENT MOSTLY CENTERED BACK ON THE BALLOON. THE STENT DELIVERY SYSTEM BALLOON WAS THEN INFLATED TO 1.5 ATMOSPHERES (ATM) TO SECURE THE STENT TO THE BALLOON. THE STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET LESION AND DEPLOYED AT THE DESIRED LOCATION. POST PROCEDURE, THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430801 ↗