Omnilink Elite 1012624-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648179310), received between Sep 6, 2016 and May 6, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 8.0X59MM OMNI ELITE SELF-EXPANDING STENT DELIVERY SYSTEM, THE STENT SLIPPED OFF THE BALLOON AND WAS SUCCESSFULLY RETRIEVED. IT IS UNKNOWN HOW THE STENT WAS RETRIEVED. 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 25096276 ↗
• InjuryJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 40% STENOSED LESION IN THE ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 8X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT BECAME DISLODGED. THEREFORE, FORCEPS WERE USED TO REMOVE THE STENT. THE PATIENT WAS SENT TO CARDIOVASCULAR SURGERY (CVS) FOR FURTHER TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299713 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUBCLAVIAN ARTERY. THE 8X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS IN PLACE; HOWEVER, IT WAS DECIDED TO USE A SHORTER STENT. THE 8X59 MM OMNILINK ELITE SDS WAS BEING REMOVED AND THE STENT DISLODGED IN THE LEFT UPPER EXTREMITY. AN 8X29 MM OMNILINK ELITE STENT WAS USED TO TREAT THE TARGET LESION. NEXT, ATTEMPTS WERE MADE TO SNARE THE STENT OR BALLOON IT IN VARIOUS WAYS BUT THIS WAS UNSUCCESSFUL. THE STENT WAS REMOVED VIA LOCAL, OPEN SURGICAL INTERVENTION IN THE OPERATING ROOM. THE PATIENT WAS KEPT OVERNIGHT BUT THERE WERE NO ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577153 ↗
• MalfunctionFeb 14, 2024Difficult to Remove; Difficult or Delayed Activation; Difficult to Remove; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY THAT WAS MODERATELY CALCIFIED. DURING DEPLOYMENT, THE OTW OMNI ELITE VASC 8.0MM/59MM/80CM BALLOON EXPANDABLE STENT WOULD NOT FULLY EXTEND PAST THE DISTAL SHEATH. HALF WAS IN AND HALF OUT. IT WAS NOT ABLE TO BE ADVANCED OR RETRIEVED SO IT HAD TO BE REMOVED AS AN ENTIRE UNIT OVER THE WIRE, STILL STUCK IN THE SHEATH. HOWEVER, THERE WERE NO REPORTED 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 18708178 ↗
• InjuryOct 18, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUBCLAVIAN ARTERY USING A RADIAL ACCESS POINT. THE 8.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH NO ISSUE; HOWEVER, ONCE AT THE LESION THE PHYSICIAN REALIZED A SMALLER SIZE STENT WAS NEEDED. THE SDS WAS ATTEMPTED TO BE REMOVED BUT RESISTANCE WAS MET WITH THE UNSPECIFIED 6FR SHEATH AND THE STENT BECAME DISLODGED ON THE UNSPECIFIED GUIDE WIRE. A NEW UNSPECIFIED 12FR SHEATH WAS INSERTED THROUGH THE RIGHT GROIN AND THE NEW OMNILINK STENT WAS SUCCESSFULLY IMPLANTED. A 3.0 UNSPECIFIED BALLOON WAS ADVANCED AND INFLATED TO HOLD THE DISLODGED 8.0X59MM OMNILINK ELITE STENT IN PLACE ON THE BALLOON AND REMOVED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651830 ↗
• MalfunctionJun 3, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER THE PROCEDURE IT WAS NOTED THAT THE 8.00X59 MM OMNILINK ELITE STENT WAS EXPIRED. THERE WERE NO OTHER DEVICE ISSUES, 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 11931606 ↗
• MalfunctionAug 28, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS COMMON ILIAC ARTERY. THE 8.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH AN UNSPECIFIED 6F GUIDING CATHETER WITHOUT ISSUE. PRIOR TO THE STENT EXITING THE DISTAL END OF THE GUIDING CATHETER THE PHYSICIAN DECIDED TO REMOVE THE SDS TO PRE-DILATE. WHILE REMOVING THE SDS THE STENT GOT STUCK IN THE GUIDING CATHETER. THE SDS AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. THE SDS WAS THEN REMOVED FROM THE GUIDING CATHETER AND THERE WAS STENT DAMAGE (THE DAMAGE WAS NOT VISIBLE DUE TO THE BLOOD). A NEW SAME SIZE OMNILINK WAS USED WITH THE SAME GUIDING CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941120 ↗
• InjuryAug 17, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE LEFT EXTERNAL ILIAC ARTERY. PREVIOUS STENTS WERE IN PLACE DOWN THE LENGTH OF THE LEFT EXTERNAL ILIAC ARTERY. A 8.0MM X 59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WHEN ADVANCING TO THE LESION FOR DIRECT STENTING. FURTHER ADVANCEMENT OF THE SDS WAS ATTEMPTED AGAINST RESISTANCE. THE STENT OF THE SDS CAUGHT ON A STRUT OF A PREVIOUSLY DEPLOYED UNKNOWN STENT AND DISLODGED FROM THE BALLOON PARTLY INSIDE THE NON-ABBOTT 6F SHEATH. THE SDS WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT THE STENT. A BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THROUGH THE SHEATH AND THE BALLOON WAS INFLATED AT THE PROXIMAL END OF THE STENT TO TRAP IT AGAINST THE SHEATH. THE SHEATH, BDC AND STENT WERE THEN REMOVED FROM THE ANATOMY AS A SINGLE UNIT. A NEW UNSPECIFIED SHEATH WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY DEPLOYING A NEW 8.0MM X 59MM OMNILINK ELITE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794595 ↗
• MalfunctionOct 6, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ILIAC. THE 8.0 MM/59 MM OTW OMNILINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WOULD NOT ADVANCE OVER THE AORTIC ARCH. DURING RETRACTION OF THE SDS THE STENT CAUGHT ON THE LIP OF THE INTRODUCER SHEATH AND DISLODGED FROM THE BALLOON INSIDE THE SHEATH. THE SHEATH, WITH THE FIRST 3/4 OF THE STENT IMPLANT INSIDE, WAS REMOVED FROM THE ANATOMY; HOWEVER, THE REMAINING 1/4 OF THE STENT (STILL INTACT) HAD TO BE REMOVED WITH THE FINGERS AS IT WAS ELONGATING. THE DECISION WAS MADE NOT TO CONTINUE TREATMENT AND THE PROCEDURE ENDED. THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6919477 ↗
• MalfunctionAug 24, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, LEFT EXTERNAL ILIAC ARTERY. ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE AREA WAS PRE-DILATED SUCCESSFULLY AND THE OTW OMNILINK ELITE STENT DELIVERY SYSTEM ADVANCED AND AN ATTEMPT WAS MADE TO CROSS OVER THE CURVE OF THE ILIAC BIFURCATION; HOWEVER, THIS FAILED. THE GUIDE WIRE WAS EXCHANGED FOR A STURDIER GUIDE WIRE AND A SECOND ATTEMPT WAS MADE TO CROSS; HOWEVER, THIS ALSO FAILED. THE STENT IMPLANT BECAME CAUGHT IN THE CALCIUM WHICH RESULTED ON THE STENT IMPLANT DISLODGING ONTO THE GUIDE WIRE. ALL DEVICES WERE REMOVED TOGETHER ALONG WITH THE DISLODGED STENT ON THE GUIDE WIRE AND THE PROCEDURE WAS LEFT BALLOON ANGIOPLASTY ONLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819163 ↗
• MalfunctionSep 6, 2016Difficult to Remove; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED ILIAC ARTERY. THE 8.0 MM X 59 MM X 80 CM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE PATIENT ANATOMY WITHOUT ISSUE. PRIOR TO STENT DEPLOYMENT, ADDITIONAL INJECTION OF DYE WAS NEEDED, THUS THE OMNILINK ELITE SDS WAS TO BE REMOVED. AS THE SDS WAS BEING REMOVED FROM AN UNSPECIFIED SHEATH THE STENT INTERACTED WITH THE SHEATH AND THE STRUTS BECAME FLARED. THE DEVICE WAS NO LONGER USED. A SAME SIZE OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5930276 ↗