Omnilink Elite 1012632-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648178559), received between Sep 6, 2018 and Nov 6, 2024 — classified as 1 injury, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A DE NOVO LESION IN THE SUBCLAVIAN ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 9X39MM OMNI LINK ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE BES FAILED TO CROSS DUE TO THE ANATOMY. THE STENT BECAME DISLODGED; THEREFORE, THE BES WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623122 ↗
• InjuryApr 1, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. DURING ADVANCING OF THE FIRST OMNILINK STENT DELIVERY SYSTEM (SDS) (1012632-39, 1050441), THE STENT DISLODGED, AND A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT SUCCESSFULLY. A SECOND OMNILINK SDS (1012632-29, 1030941) WAS ADVANCED INTO THE VESSEL AND THE STENT DISLODGED AS WELL. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED WITH THE DELIVERY SYSTEM BUT A CUT DOWN OF THE VESSEL WAS PERFORMED TO REMOVE THE SECOND DISLODGED STENT. THERE WAS SOME RESISTANCE NOTED DURING ADVANCEMENT DUE TO A SHARP ANGLE IN THE VESSEL. A THIRD OMNILINK SDS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978441 ↗
• MalfunctionMar 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE STENT WAS ALREADY DISLODGED FROM THE BALLOON IN THE PACKAGING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653490 ↗
• MalfunctionOct 2, 2020Device Misassembled During Manufacturing /Shipping; Device Dislodged or Dislocated; Device Misassembled During Manufacturing /Shipping; Device Dislodged or Dislocated

  IT WAS REPORTED THAT OUT OF PACKAGING, THE 9.0X39MM OMNILINK STENT AND PROTECTIVE SHEATH WERE OFF OF THE DELIVERY CATHETER AND ON THE BOTTOM OF THE POUCH. THERE WAS NO PATIENT INVOLVEMENT. A NEW 8.0X59MM OMNILINK STENT WAS USED 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: No Patient Involvement

  MAUDE report 10623414 ↗
• MalfunctionSep 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 9.0 X 39 MM OMNILINK ELITE STENT DELIVERY SYSTEM PACKAGE WAS OPENED AND IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SECOND OMNILINK ELITE STENT DELIVERY SYSTEM WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7853327 ↗