Omnilink Elite 1012630-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648178450), received between May 3, 2018 and Oct 12, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18, 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.

• MalfunctionOct 12, 2022Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 7X 15 MM, CIRCUMFERENTIAL BIFURCATION OF THE PULMONARY ARTERY WITH 75% STENOSIS. PRE-DILATATION WAS NOT PERFORMED AND THE 7X19 MM OMNILINK ELITE STENT WAS INFLATED ONCE TO 11 ATMOSPHERES (ATM) AND THEN UP TO 14 ATM. THE BALLOON RUPTURED AT 14 ATM FOR 30 SECONDS; HOWEVER, THE STENT WAS DEPLOYED AT THE INTENDED LOCATION. NEXT, THE 10X19 MM OMNILINK ELITE STENT WAS INFLATED TO 11 ATM AND THEN UP TO 14 ATM TO DEPLOY THE STENT AND 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 15591906 ↗
• InjuryAug 31, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT RENAL ARTERY. THE 7.0X19MM OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BESS WAS ADVANCED INTO THE ANATOMY; HOWEVER, EACH TIME AN ATTEMPT TO ADVANCE WAS MADE THE BESS, THE SHEATH AND WIRE WOULD DISENGAGE AND COME OUT OF THE ARTERY. DURING ONE ATTEMPT TO ADVANCE THE BESS IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE SYSTEM. THE STENT WAS FOUND DISLODGED IN THE RIGHT ILIAC ARTERY. A FILTER WAS USED TO SECURE THE STENT AT ITS LOCATION AND THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE STENT. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED AND THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329514 ↗
• InjuryJul 20, 2022Difficult to Remove; Device Damaged by Another Device; Migration; Difficult to Remove; Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A TARGET LESION IN THE MODERATELY CALCIFIED RIGHT COMMON CAROTID ARTERY OSTIUM. A NON-ABBOTT EMBOLIC PROTECTION DEVICE FILTER AND WIRE WERE PLACED AT THE TARGET SITE AND PRE-DILATATION WAS PERFORMED. THE OMNILINK STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. POST DILATATION WAS PERFORMED AND THE NON-ABBOTT FILTER RETRIEVAL CATHETER WAS ADVANCED. RESISTANCE WAS NOTED ADVANCING THE RETRIEVAL CATHETER AND THE CATHETER CAUGHT ON THE EDGE OF THE OMNILINK STENT. THE FILTER WIRE ADVANCED INTO THE STENT AND THE PHYSICIAN TRIED MANIPULATING THE RETRIEVAL CATHETER TO REMOVE IT; HOWEVER, THE FILTER POPPED INTO THE STENT AND THE FILTER WIRE SNAPPED. THE FILTER REMAINED CAUGHT IN THE OMNILINK STENT AND WAS UNABLE TO BE RETRIEVED. THE STENT WAS NOTED TO BE DAMAGED, AS A RESULT OF THE INTERACTION WITH THE RETRIEVAL CATHETER, AND MOVED A SMALL AMOUNT INTO THE AORTA. THE PATIENT WAS SENT FOR A SURGICAL PROCEDURE TO REMOVE THE NON-ABBOTT FILTER. THE DECISION WAS MADE TO LEAVE THE OMNILINK STENT IN PLACE, AS THERE WAS CONCERN OF CAUSING MORE DAMAGE. A SURGICAL BYPASS PROCEDURE WAS PERFORMED, FROM THE AORTA TO THE COMMON CAROTID ARTERY, ABO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070854 ↗
• MalfunctionNov 1, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 7X19MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED TOWARDS THE TARGET LESION WHEN THE STENT BECAME LOOSE ON THE BALLOON DUE TO THE HEAVILY CALCIFIED ANATOMY. THE BES WAS REMOVED, WITH THE STENT INTACT. A SECOND 7X19MM OMNI ELITE BES WAS THEN ADVANCED, BUT THIS STENT ALSO BECAME LOOSE ON THE BALLOON DUE TO THE CALCIUM IN THE ANATOMY, AND THEY WITHDREW THIS BES AS WELL. HOWEVER, DURING REMOVAL, THE STENT DISLODGED OFF THE BALLOON INTO THE INTRODUCER SHEATH AND THE WHOLE SYSTEM WAS REMOVED WITH THE STENT REMAINING IN THE SHEATH. THE PROCEDURE WAS ABORTED AT THIS POINT. THERE WERE 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 12733918 ↗
• MalfunctionNov 1, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 7X19MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED TOWARDS THE TARGET LESION WHEN THE STENT BECAME LOOSE ON THE BALLOON DUE TO THE HEAVILY CALCIFIED ANATOMY. THE BES WAS REMOVED, WITH THE STENT INTACT. A SECOND 7X19MM OMNI ELITE BES WAS THEN ADVANCED, BUT THIS STENT ALSO BECAME LOOSE ON THE BALLOON DUE TO THE CALCIUM IN THE ANATOMY, AND THEY WITHDREW THIS BES AS WELL. HOWEVER, DURING REMOVAL, THE STENT DISLODGED OFF THE BALLOON INTO THE INTRODUCER SHEATH AND THE WHOLE SYSTEM WAS REMOVED WITH THE STENT REMAINING IN THE SHEATH. THE PROCEDURE WAS ABORTED AT THIS POINT. THERE WERE 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 12733887 ↗
• InjuryMay 3, 2018Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 7.0 X 19 MM OMNILINK ELITE VASCULAR STENT SYSTEM WAS USED AND CROSSED THE LESION; HOWEVER, THE DEVICE MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THEREFORE, THE STENT SYSTEM WAS RETRACTED AND MET RESISTANCE WITH THE ANATOMY DURING REMOVAL AS WELL. THE STENT THEN BECAME ENTANGLED WITH THE ANATOMY; CAUSING THE STENT TO DISLODGE FROM THE BALLOON AND PREMATURELY EXPAND. AN UNSPECIFIED CORONARY BALLOON DILATATION CATHETER WAS THEREFORE USED TO POST-DILATE THE STENT AS IT WAS NOT PROPERLY APPOSED TO THE LESION. NO FURTHER TREATMENT WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484544 ↗