Omnilink Elite 1012633-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648178580), received between May 31, 2017 and Jan 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• MalfunctionJan 3, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Insert; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. A 9.0X29MM OMNILINK ELITE STENT WAS PLACED WITHOUT ISSUE. A 10.0X29MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER IT FELT LIKE THE STENT WAS GETTING HUNG UP ON THE PREVIOUSLY PLACED STENT THEREFORE THE SDS WAS REMOVED. AN ATTEMPT WAS MADE TO ADVANCE THE SDS AGAIN HOWEVER RESISTANCE WAS MET WITH THE 7FR SHEATH AND IT WAS NOTED THE DISTAL END OF THE STENT STRUTS WERE MANGLED. A NEW 9MM OMNILINK ELITE 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. RETURN DEVICE ANALYSIS OF THE 10.0X29MM OMNILINK ELITE NOTED THE STENT WAS STATIONARY ON THE BALLOON HOWEVER WAS NOT LOCATED WITHIN THE MARKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066186 ↗
• MalfunctionOct 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING OPENING OF THE 10X29MM OMNILINK BALLOON EXPANDABLE STENT (BES), THE DEVICE WAS REMOVED FROM THE HOOP WITHOUT RESISTANCE; HOWEVER, WHEN THE SHEATH WAS REMOVED TO THE TIP THE STENT BECAME DISLODGED FROM THE BALLOON. ANOTHER OMNILINK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE WAS RECEIVED, AND THE STENT WAS MISSING. THE ACCOUNT STATED THAT THE STENT WAS RETURNED WITH THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913193 ↗
• MalfunctionApr 15, 2021Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT PULMONARY ARTERY. THE 10.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM COULD NOT BE INSERTED IN AN UNSPECIFIED SHEATH THEN THE STENT FELL OFF OF THE BALLOON. THE DEVICE WAS REPLACED WITH A NEW OMNILINK ELITE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11671639 ↗
• MalfunctionMay 31, 2017Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A 10 X 29 MM OMNILINK ELITE STENT DELIVERY SYSTEM, THE STENT WAS OBSERVED TO BE PROXIMALLY MISALIGNED ON THE BALLOON AND NO LONGER WITHIN THE MARKERS. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW OMNILINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6603308 ↗