Omnilink Elite 1012632-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648178535), received between Mar 3, 2020 and Feb 29, 2024 — classified as 2 injuries, 2 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 16, 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.

• InjuryFeb 29, 2024Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE BRACHIOCEPHALIC ARTERY. AFTER THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER, THE 9.0X19MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO 11 ATMOSPHERES (ATM) FOR 10 SECONDS. WHEN THE SDS WAS ATTEMPTED TO BE REMOVED, THE STENT MIGRATED PROXIMAL TO THE TARGET LESION. A NON-ABBOTT BALLOON CATHETER WAS USED TO OVER DILATE THE MIGRATED STENT TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18806185 ↗
• MalfunctionJan 6, 2022Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY. A 9X19MM OMNI ELITE VASCULAR BALLOON EXPANDABLE STENT (BES) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY. DEPLOYMENT WAS INITIATED AT THE TARGET LESION; HOWEVER, ONE OF THE STENT STRUTS WAS NOTED AS MANGLED AND DEPLOYMENT WAS ABORTED. THE DELIVERY SYSTEM AND PARTIALLY DEPLOYED STENT WAS REMOVED AS ONE UNIT WITHOUT ISSUE, AND ANOTHER OMNI ELITE BES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURNED DEVICE ANALYSIS FOUND THAT THE STENT WAS DISLODGED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177094 ↗
• InjuryAug 17, 2020Difficult or Delayed Activation; Migration; Difficult or Delayed Activation; Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TARGET LESION IN THE COMMON ILIAC ARTERY. WHEN DEPLOYING THE 9.0MMX19MMX135CM OMNILINK STENT IN THE TARGET LESION, THERE WAS LACK OF DISTAL DEPLOYMENT ON THE DISTAL EDGE OF THE STENT AND THE STENT MIGRATED INTO HEALTHY TISSUE IN THE EXTERNAL ILIAC ARTERY. THE DELIVERY SYSTEM WAS WITHDRAWN TO THE MIGRATED STENT AND THE STENT WAS IMPLANTED IN HEALTHY TISSUE AND FULLY APPOSED TO THE VESSEL WALL. A SECOND OMNILINK STENT WAS IMPLANTED WITHOUT ISSUE IN THE TARGET LESION. NO ADDITIONAL TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10417705 ↗
• MalfunctionMar 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE OMNILINK ELITE STENT DELIVERY SYSTEM, AFTER REMOVAL FROM THE DISPENSER COIL AND REMOVAL OF THE PROTECTIVE SHEATH, WITHOUT RESISTANCE, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9782095 ↗