Omnilink Elite 1012629-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648179518), received between Mar 6, 2017 and Mar 24, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON ILIAC ARTERY LESION WITH 95% STENOSIS. A 6.0X19 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY HOWEVER THE STENT DISLODGED FROM THE BALLOON. AN ADDITIONAL 6.0X19 MM OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24682537 ↗
• MalfunctionJul 31, 2025Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL ILIAC ARTERY. A 6FR INTRODUCER SHEATH WAS ADVANCED BEYOND THE TARGET LESION, THEN A 6X19MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ADVANCED TO THE TARGET LESION. THE INTRODUCER SHEATH WAS PULLED BACK TO DEPLOY THE STENT; HOWEVER, PRIOR TO ATTEMPTING TO DEPLOY THE STENT, THE PHYSICIAN WAS NOT SATISFIED WITH THE STENTS POSITION. THEREFORE, THE BES WAS PULLED BACK INTO THE INTRODUCER SHEATH, BUT MET WITH RESISTANCE WITH THE INTRODUCER SHEATH AND THE STENT OF THE BES BECAME DISLODGED AND STUCK WITH INTRODUCER SHEATH. THE BES AND THE INTRODUCER SHEATH WERE ABLE TO REMOVED AS A SINGLE UNIT. A XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674622 ↗
• MalfunctionJun 13, 2025Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE 6.0X19MM OMINLINK ELITE WAS ADVANCED TO THE TARGET SITE; HOWEVER, WHEN ATTEMPTING TO INFLATE A LEAK WAS OBSERVED OUTSIDE THE PATIENT AT THE CONNECTION SITE BETWEEN THE DEVICE AND UNSPECIFIED INDEFLATOR. THEREFORE, THE DEVICE WAS REMOVED AND A NEW UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 22205193 ↗
• InjuryOct 12, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Activation Failure; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH SEVERE CALCIUM IN THE ILIAC ARTERY. THE 6.0 X 19 MM OMNI ELITE STENT SYSTEM WAS PREPARED PER THE INSTRUCTION FOR USE (IFU) WITH NO ISSUES NOTED AND ADVANCED BUT COULD NOT CROSS THE LESION DUE TO A SHARP ANGULATION IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE OMNI ELITE, BUT WHEN THE DEVICE WAS PULLED BACK THERE WAS RESISTANCE WITH THE VESSEL AND THE STENT PARTIALLY DEPLOYED INSIDE THE SHEATH. DURING REMOVAL OF THE DEVICE, THE STENT DISLODGED COMPLETELY AND EMBOLIZED IN THE GROIN. THE PATIENT HAD MINOR SURGERY TO REMOVE THE DISLODGED STENT FROM THE GROIN, PROLONGING HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 12616298 ↗
• MalfunctionSep 23, 2017Positioning Failure; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE LEFT SUBCLAVIAN ARTERY. THE 6.0 X 19 MM OMNI ELITE STENT SYSTEM WAS PREPARED PER THE INSTRUCTION FOR USE WITH NO ISSUES NOTED AND ADVANCED TO THE LESION WITHOUT RESISTANCE. THE DEVICE WAS PRESSURIZED TO NOMINAL PRESSURE; HOWEVER, THE STENT DID NOT DEPLOY. WHEN THE DEVICE WAS PULLED BACK WITH SLIGHT RESISTANCE INTO THE SHEATH, THE STENT DISLODGED INSIDE THE SHEATH. OUTSIDE THE PATIENTS ANATOMY, THE DISLODGED STENT WAS RETRIEVED FROM THE SHEATH. A 7.0 X 19 MM OMNI ELITE STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6889057 ↗
• MalfunctionMar 6, 2017Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT RENAL DESCENDING ARTERY. THE 6.0 MM/19 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT DEPLOYED WITHOUT ANY ISSUES. THE SDS WAS REMOVED FROM THE PATIENT. THE VESSEL WAS REACCESSED WITH THE GUIDING CATHETER, AT WHICH TIME THE TIP OF THE GUIDING CATHETER CAME INTO CONTACT WITH THE PROXIMAL END OF THE DEPLOYED STENT THAT WAS PROTRUDING INTO THE AORTA AND BENT THE STENT. THIS DID NOT CAUSE ANY FLOW-LIMITING PROBLEMS; THEREFORE, NO TREATMENT WAS REQUIRED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6381845 ↗