Omnilink Elite 1012633-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648178573), received between Feb 7, 2020 and Apr 23, 2021 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE LEFT RADIAL ARTERY WITH MILD CALCIFICATION. THE 10X19 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM PREMATURELY. NO ATTEMPT WAS MADE TO RETRIEVE THE STENT BUT THE STENT WAS EMBEDDED IN HEALTHY TISSUE BY A BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11718665 ↗
• InjuryFeb 7, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 10.0X19 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) SUCCESSFULLY CROSSED THE HEAVILY TORTUOUS, MILDLY CALCIFIED, RIGHT SUBCLAVIAN ARTERY, BUT THE GUIDE WIRE THAT THE SDS WAS LOADED ON, WAS TOO STIFF. THE PHYSICIAN INTENDED TO SWITCH OUT THE GUIDE WIRE TO ALLOW FOR CORRECT POSITIONING OF THE SDS. DURING REMOVAL OF THE SDS, RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT BEGAN TO COME OFF THE SDS. THE PHYSICIAN INFLATED THE SDS TO TWO ATMOSPHERES TO PREVENT THE STENT FROM FULLY DISLODGING. THE SDS WAS SUCCESSFULLY RETRACTED INSIDE THE 7 FRENCH SHEATH. DURING REMOVAL OF THE SHEATH AND SDS AS A UNIT, THE SHEATH CAME OUT FIRST, WHILE THE SDS WAS STILL IN THE BODY. THE STENT THEN DISLODGED FROM THE SDS IN THE ILIAC ARTERY. THE SHEATH INTRODUCER WAS USED TO ADVANCE THE STENT TO THE AORTA SO THE SNARE COULD CAPTURE THE DISLODGED STENT. THE SNARE WAS RETRACTED INTO THE SHEATH WITH DIFFICULTY AND THE DEVICES WERE REMOVED AS A UNIT THROUGH THE COMMON FEMORAL ARTERY ACCESS. INTIMAL ARTERY DAMAGE WAS NOTED AT THE COMMON FEMORAL, SO BALLOON ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY TREAT THE DAMAGE. THERE WAS NO PERFORATION, NO EXCESS BLEEDING, AND NO FLOW LIMITING

  Patient problems: Tissue Damage

  MAUDE report 9682875 ↗