Omnilink Elite 1012625-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648179327), received between Jan 25, 2017 and Apr 4, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• MalfunctionApr 4, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT SUBCLAVIAN VESSEL THAT WAS 100% STENOSED. RESISTANCE WAS NOTED WHEN ADVANCING THE 9.0X19MMX80CM OMNI ELITE STENT SYSTEM IN THE INTRODUCER SHEATH. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE GUIDING SHEATH WAS REPLACED. AND ANOTHER OMNILINK ELITE STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED THE STENT WAS DISLODGED FROM THE BALLOON.IT IS POSSIBLE THAT THE STENT DISLODGED DURING REMOVAL FROM THE INTRODUCER SHEATH; HOWEVER, THE PHYSICIAN WAS NOT AWARE OF THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678273 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE 9.0X19MM OMNILINK ELITE DELIVERY SYSTEM WAS NOTED TO HAVE MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. ONCE REMOVED IT WAS NOTED THAT THE STENT DISLODGED ON THE DELIVERY SYSTEM. NOT COMPLETELY OFF BUT NOT WELL PLACED. ANOTHER SAME SIZE OMINILINK WAS USED TO COMPLETE THE PROCEDURE. 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 15510531 ↗
• InjuryDec 15, 2020Difficult 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 HEAVILY CALCIFIED, MODERATELY TORTUOUS DE NOVO FEMORAL ARTERY. THE 9.0X19MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WAS MET WITH THE SHEATH DURING WITHDRAWAL AND THE STENT DISLODGED. THE DISLODGED STENT WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW 8.0X19MM OMNILINK STENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11013087 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT OSTIAL SUBCLAVIAN ARTERY, THE EMBOSHIELD NAV6 WAS USED FOR EMBOLIC PROTECTION. THE OMNILINK ELITE STENT WAS IMPLANTED WITH A GOOD RESULT AND WITHOUT ISSUE. THE NAV6 WAS REMOVED AND NO DEBRIS WAS NOTED IN THE FILTER BASKET. SEVERAL HOURS LATER, WHILE THE PATIENT WAS STILL IN RECOVERY, THE PATIENT EXPERIENCED A LEFT HEMISPHERIC STROKE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 7501107 ↗
• MalfunctionDec 1, 2017Unstable; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS 30% STENOSED FOR A PEDIATRIC PATIENT. A 9.0 X 19MM OMNILINK ELITE WAS ADVANCED TO THE TARGET LESION. HOWEVER, THE STENT SHIFTED PROXIMALLY FROM THE BALLOON WHILE ATTEMPTING TO CROSS IN THE PULMONARY ARTERY. THE DEVICE WAS SIMPLY WITHDRAWN AS A SINGLE UNIT ALONG WITH THE SHEATH. THE PROCEDURE WAS THEN COMPLETED BECAUSE THE SITE HAD NO ADDITIONAL 9.0 X 19MM OMNILINK ELITE IN THEIR INVENTORY. 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 7076727 ↗
• MalfunctionJan 25, 2017Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE 9.0 X 19 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) AND THE STENT CAME OFF WITH THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. ANOTHER OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6277901 ↗