Omnilink EliteRecalls & reported problems across all models

We found 42 models of Omnilink Elite by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 317 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2016 and Aug 20, 2026 — classified as 1 death, 149 injuries, 167 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (207 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Omnilink Elite problems

Omnilink Elite models

42 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Omnilink Elite 1012631-39

  STENT, ILIAC
  27 reports
• Omnilink Elite 1012632-29

  STENT, ILIAC
  25 reports
• Omnilink Elite 1012631-59

  STENT, ILIAC
  21 reports
• Omnilink Elite 1012624-39

  STENT, ILIAC
  1 death21 reports
• Omnilink Elite 1012631-29

  STENT, ILIAC
  16 reports
• Omnilink Elite 1012625-29

  STENT, ILIAC
  15 reports
• Omnilink Elite 1012630-59

  STENT, ILIAC
  12 reports
• Omnilink Elite 1012631-19

  STENT, ILIAC
  11 reports
• Omnilink Elite 1012624-29

  STENT, ILIAC
  11 reports
• Omnilink Elite 1012624-59

  STENT, ILIAC
  11 reports
• Omnilink Elite 1012625-39

  STENT, ILIAC
  9 reports
• Omnilink Elite 1012624-19

  STENT, ILIAC
  8 reports
• Omnilink Elite 1012629-39

  STENT, ILIAC
  8 reports
• Omnilink Elite 1012633-39

  STENT, ILIAC
  7 reports
• Omnilink Elite 1012623-29

  STENT, ILIAC
  7 reports
• Omnilink Elite 1012623-39

  STENT, ILIAC
  7 reports
• Omnilink Elite 1012626-39

  STENT, ILIAC
  7 reports
• Omnilink Elite 1012630-19

  STENT, ILIAC
  6 reports
• Omnilink Elite 1012630-29

  STENT, ILIAC
  6 reports
• Omnilink Elite 1012625-19

  STENT, ILIAC
  6 reports
• Omnilink Elite 1012629-19

  STENT, ILIAC
  6 reports
• Omnilink Elite 1012632-39

  STENT, ILIAC
  5 reports
• Omnilink Elite 1012629-29

  STENT, ILIAC
  5 reports
• Omnilink Elite 1012629-59

  STENT, ILIAC
  5 reports
• Omnilink Elite 1012632-19

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012633-29

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012633-59

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012622-19

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012622-39

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012622-59

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012623-19

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012623-59

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012625-59

  STENT, ILIAC
  4 reports
• Omnilink Elite 1012630-39

  STENT, ILIAC
  3 reports
• Omnilink Elite 1012632-59

  STENT, ILIAC
  3 reports
• Omnilink Elite 1012622-29

  STENT, ILIAC
  3 reports
• Omnilink Elite 1012633-19

  STENT, ILIAC
  2 reports
• Omnilink Elite 1012623-16

  STENT, ILIAC
  2 reports
• Omnilink Elite 1012626-29

  STENT, ILIAC
  2 reports
• Omnilink Elite 1012626-59

  STENT, ILIAC
  2 reports
• Omnilink Elite 1012622-16

  STENT, ILIAC
  1 report
• Omnilink Elite 1012626-19

  STENT, ILIAC
  1 report

Recent Omnilink Elite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Failure to Advance; Device Dislodged or Dislocated

  It was reported that the procedure was to treat an internal iliac artery lesion with 90% stenosis. A 7x39 mm Omnilink Elite stent delivery system (SDS) was advanced; however, it failed to cross the lesion due to the anatomy. The 6x39 mm Omnilink Elite SDS was advanced and it also failed to cross the lesion. The stent then became dislodged from the SDS and moved into the aorta. A new 10mm Omnilink stent was implanted to embed the dislodged stent in the iliac artery and complete the procedure. There was a clinically significant delay in the procedure. No additional information was provided.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50358877 ↗
• MalfunctionJun 26, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY. THE 9.0X29MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT SNAGGED ON THE CALCIFIED PLAQUE AND STARTED TO DISLODGE FROM THE BALLOON THEREFORE THE SDS WAS REMOVED. ANOTHER OMNILINK WAS DEPLOYED IN THE TARGET LESION. 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 25634908 ↗
• InjuryJun 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY TORTUOUS MESENTERIC ARTERY THAT IS 80% STENOSED. THE 7.0X29MM OVER-THE-WIRE OMNI ELITE BALLOON-EXPANDABLE STENT (BES) DELIVERY SYSTEM WAS ADVANCED TO THE LESION. UPON POSITIONING THE BES FOR DEPLOYMENT, THE STENT DISLODGED. BY PARTIALLY INFLATING THE BALLOON, THE STENT WAS ABLE TO BE REPOSITIONED AND IMPLANTED AT THE INTENDED TARGET LESION. 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 25628930 ↗
• MalfunctionMay 22, 2026Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT COMMON ILIAC ARTERY (CIA) LESION. AN 8X29 MM OMNILINK ELITE STENT WAS IMPLANTED. DURING THE CATHETER EXCHANGES FOR POST DILATATION, WIRE POSITION WAS LOST AND THE POST DILATATION BALLOON WAS NOT ABLE TO ADVANCE FROM THE RADIAL APPROACH. THE DECISION WAS MADE TO POST DILATE VIA AN UP AND OVER APPROACH FROM THE RIGHT COMMON FEMORAL ARTERY. DURING THE MANIPULATION OF CATHETERS AND WIRES THE OMNILINK STENT MOVED DISTALLY IN THE CIA. THE STENT WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257817 ↗
• InjuryMay 19, 2026Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS CELIAC ARTERY LESION WITH 90% STENOSIS. A 9X29 MM OMNILINK ELITE BALLOON EXPANDING STENT WAS ADVANCED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO THE USE OF 0.014 INCH GUIDE WIRE. THE STENT THEN CAME OFF THE BALLOON WHILE ATTEMPTING TO CROSS THE LESION. A SNARE WAS USED TO RETRIEVE THE STENT AND EVERYTHING WAS PULLED OUT OF THE BODY TOGETHER. ACCESS WAS LOST AND THE PROCEDURE WAS ABORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220121 ↗
• InjuryMay 19, 2026Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT COMMON ILIAC ARTERY LESION. AN 8X59 MM OMNILINK ELITE STENT WAS IMPLANTED WITHOUT ISSUE. THE OMNILINK BALLOON WAS THEN USED FOR POST-DILATION AT A HIGHER ATMOSPHERE; HOWEVER, THE DISTAL END OF THE STENT BECAME CRUSHED DURING ADVANCEMENT OF THE BALLOON CATHETER. AN ADDITIONAL OMNILINK STENT WAS USED TO COVER THE DAMAGED SECTION AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219850 ↗
• MalfunctionMay 15, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS COMMON ILIAC ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 8.0X39MM OMNI ELITE OTW BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET WITH THE GUIDING CATHETER. UPON REMOVAL OF THE SDS, THE STENT DISLODGED FROM THE BALLOON BUT REMAINED TIGHTLY CRIMPED ON THE SDS CATHETER. A 7.0X39MM OMNILINK WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25187565 ↗
• InjuryMay 11, 2026Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT COMMON ILIAC ARTERY LESION. THE 8X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS NOT PREPPED WITH NEGATIVE PRESSURE PRIOR TO USE. THE SDS WAS ADVANCED TO THE LESION VIA THE LEFT COMMON FEMORAL ARTERY THROUGH THE 7FR SHEATH. HOWEVER, WHILE PASSING THROUGH THE LEFT ILIAC ARTERY, SLIGHT RESISTANCE WAS NOTED AND THE STENT WAS STRIPPED FROM THE BALLOON. THE STENT THEN TRAVELED DOWN TO THE RIGHT COMMON FEMORAL ARTERY (RCFA). A 5X40 MM BALLOON WAS USED TO DEPLOY THE STENT IN THE RCFA. A NEW 8X59 MM OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25139742 ↗
• 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 ↗
• MalfunctionMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THE STENT DISLODGED FROM THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058717 ↗
• MalfunctionApr 21, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE 7.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND INFLATION WAS ATTEMPTED HOWEVER THE BALLOON DID NOT INFLATE AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED AND THE STENT WAS STILL INTACT ON THE BALLOON. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. POST PROCEDURE THE OMNILINK ELITE WAS ABLE TO BE INFLATED ON THE TABLE HOWEVER IT WAS DIFFICULT WITH A LOT OF RESISTANCE. 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 24939154 ↗
• InjuryMar 31, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT HAS BEEN REPORTED THE PROCEDURE WAS TO TREAT 80% STENOSED LESIONS IN THE LEFT EXTERNAL ILIAC ARTERY AND LEFT COMMON ILIAC ARTERY WITH MODERATE CALCIFICATION. ON (B)(6) 2026 THE 8X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ADVANCED TO THE TARGET LESION AND THE WHILE REPOSITIONING THE BES WITH DIFFICULTY, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM BALLOON. THEN, A 7X39MM OMNI ELITE BES WAS IMPLANTED; HOWEVER, POST STENT IMPLANTATION AN UNSPECIFIED GUIDE WIRE (GW) WAS BEING ADVANCED TO ACCESS THE PATIENTS LEFT SIDE WHEN THE GW BECAME ENTANGLED WITH THE IMPLANTED STENT. THEREFORE, ON (B)(6) 2026 CUTDOWN SURGERY WAS PERFORMED TO REMOVE BOTH THE STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743535 ↗
• MalfunctionMar 30, 2026Failure to Advance; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE 7.0X59MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AND EXPAND. 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 24712628 ↗
• MalfunctionMar 25, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. ONCE THE SDS WAS REMOVED FROM THE PATIENT ANATOMY IT WAS NOTED THE STENT HAD SHIFTED ON THE BALLOON. A NEW DEVICE WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24690087 ↗
• MalfunctionMar 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON ILIAC ARTERY LESION WITH 95% STENOSIS. A 6.0X19 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY HOWEVER THE STENT DISLODGED FROM THE BALLOON. AN ADDITIONAL 6.0X19 MM OMNILINK ELITE STENT WAS USED TO 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 24682537 ↗

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