Omnilink Elite 1012622-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648179198), received between Dec 16, 2016 and Mar 20, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. DURING ADVANCEMENT OF THE 6 X 29 MM OMNILINK ELITE BALLOON EXPANDING STENT (BES), THE BES BECAME STUCK IN A 7F INTRODUCER SHEATH AND THE STENT BECAME DISLODGED. THEREFORE, THE BES AND SHEATH HAD TO BE REMOVED AS A SINGLE UNIT TO PROCEED WITH THE PROCEDURE. ANOTHER OMNILINK ELITE BES WAS USED TO CONTINUE 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 24650495 ↗
• InjuryJun 23, 2025Off-Label Use; Material Rupture; Difficult or Delayed Activation; Off-Label Use; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT VERTEBRAL ARTERY. THE 6.0X29MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING THE FIRST INFLATION TO 11 ATMOSPHERES, THE BALLOON LOST PRESSURE AND COULD NOT BE RE-INFLATED. A NON-ABBOTT BALLOON CATHETER WAS USED TO POST DILATE AND ENSURE THE STENT WAS APPOSED TO THE VESSEL WALL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307669 ↗
• InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD THREE OMNI ELITE AND ONE ABSOLUTE PRO STENTS IMPLANTED IN THE RIGHT COMMON ILIAC AND LEFT COMMON ILIAC ARTERIES ON (B)(6) 2013. APPROXIMATELY A YEAR LATER, THE PATIENT STARTED EXPERIENCING TINGLING AND SEVERE PAIN DOWN BOTH LEGS. MEDICATION HAS BEEN PRESCRIBED. THE PATIENT HAS ALWAYS BEEN SENSITIVE TO METAL; THEREFORE, AN ALLERGY KIT HAS BEEN REQUESTED BY THE ALLERGIST. ADDITIONALLY, THE PATIENT SUFFERS OF AN OCCLUSIVE PERIPHERAL DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Numbness; Pain

  MAUDE report 6182547 ↗