Omnilink Elite 1012626-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648179396), received between Jan 2, 2019 and Dec 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 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.

• MalfunctionDec 6, 2019Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED ILIAC ARTERY. THE 10.0 X 59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, WITH RESISTANCE, TO THE TARGET LESION. THE SDS BALLOON WAS ATTEMPTED TO BE INFLATED, BUT THE STENT REMAINED ON THE STENT DELIVERY SYSTEM. THE SDS WAS REMOVED WITHOUT RESISTANCE AND THE STENT REMAINED ON THE DELIVERY SYSTEM. ADDITIONAL PREDILATATION WAS PERFORMED AND A SECOND OMNILINK ELITE WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9434299 ↗
• MalfunctionJan 2, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED COMMON ILIAC ARTERY AND PLAQUE AT THE OSTIUM WAS NOTED. PRE-DILATATION WAS NOT PERFORMED. A 10X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED SLIGHTLY PAST THE LESION AND WHEN PULLING THE SDS BACK, RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT PARTIALLY CAME OFF THE BALLOON APPROXIMATELY 5MM. THE PHYSICIAN MADE THE DECISION TO DEPLOY THE STENT AT THAT LOCATION TO PREVENT DISLODGEMENT OF THE STENT. THE STENT WAS PARTIALLY IN THE LESION AND PARTIALLY IN HEALTHY TISSUE. A 10X29 MM OMNILINK ELITE STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE REMAINING PORTION OF THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209503 ↗