Omnilink Elite 1012626-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648179389), received between Jun 5, 2017 and Jun 26, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A COMMON ILIAC ARTERY. A NON-ABBOTT GUIDE WIRE AND GUIDE CATHETER WERE ADVANCED TO THE EXTERNAL ILIAC ARTERY ON THE RIGHT AND SIGNIFICANT STENOSIS WAS PRESENT IN THE COMMON FEMORAL ARTERY THEREFORE, THE WIRE WAS EXCHANGED TO A .018 COMMAND GUIDE WIRE. LASER ATHERECTOMY WAS PREFORMED 3 TIMES WITH ANGIO SHOWING SIGNIFICANT IMPROVEMENT FLOW. A 10X39MM OMNILINK ELITE STENT WAS ADVANCED OVER THE WIRE INTO THE DISTAL AORTA AND DEPLOYED; HOWEVER, THE BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES NOT ALLOWING THE STENT TO FULLY EXPAND. A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE USED FOR POST DILATATION: HOWEVER, RUPTURED AT 6 ATMOSPHERES. (BDC). DURING REMOVAL RESISTANCE WAS FELT WHEN PULLING INTO THE SHEATH AND THE BDC SEPARATED IN HALF AND THE DISTAL MARKER STILL ON THE WIRE JUST OUTSIDE THE SHEATH. AN ATTEMPT WAS MADE TO PULL IN THE SEPARATED PORTION INTO THE SHEATH WHEN ASPIRATING; HOWEVER, WAS UNSUCCESSFUL AS THE BALLOON CONTINUED TO GET STUCK ON THE ARTERIAL WALL. A HEMOSTAT WAS USED TO PULL THE SEPARATED PORTION OF THE BALLOON FROM THE ARTERIOTOMY ALL SEPARATED PORTIONS WERE REMOVED. A PERCLOSE WAS U

  Patient problems: Vascular Dissection

  MAUDE report 22338932 ↗
• InjuryMay 9, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. THE 10X39MM OMNILINK ELITE BALLOON EXPANDING STENT (BES) WAS ADVANCED TO THE TARGET LESION. WHEN PHYSICIAN PULLED BACK THE BES TO GET BETTER POSITIONING PRIOR TO DEPLOYMENT, THE STENT DID NOT COME BACK WITH DELIVERY SYSTEM AND BECAME DISLODGED IN THE ILIAC ARTERY. THEREFORE, A SNARE WAS USED TO PULL THE STENT INTO THE SHEATH; HOWEVER, THE SNARE WAS NOT ABLE TO PULL THE STENT BACK INTO THE SHEATH. AS A RESULT, THE PHYSICIAN HAD TO REMOVE ALL DEVICES AS A SINGLE UNIT INCLUDING THE SNARE AND STENT. DURING THE SNARING AND REMOVAL PROCESS THE STENT BECAME MANGLED. ANOTHER SAME SIZE OMNILINK BES WAS USED TO CONTINUE THE PROCEDURE. 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 21997961 ↗
• InjuryNov 7, 2023Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH STENOSIS IN A STENT GRAFT. THE 10X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND PLACED FOR KISSING TECHNIQUE. DEPLOYMENT WAS ATTEMPTED; HOWEVER, ONLY THE DISTAL PORTION OF THE STENT DEPLOYED. THE STENT DISLODGED AND MOVED TO THE ABDOMINAL AORTA.. A SNARE WAS ATTEMPTED TO REMOVE THE STENT BUT WAS UNSUCCESSFUL. THE DISLODGED STENT COULD NOT BE REMOVED SO IT WAS EMBEDDED TO THE VESSEL WALL WITH A STENT GRAFT. A NEW OMNILINK ELITE SDS WAS USED TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18085123 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PRIOR TO THE PROCEDURE THE PHYSICIAN WANTED TO TEST IF THE 10.0X39MM OMNILINK ELITE STENT WOULD ADVANCE THROUGH A 7FR SHEATH. THE DEVICE ADVANCED WITHOUT ISSUE; HOWEVER, WHEN PULLING BACK RESISTANCE WAS MET WITH THE SHEATH AND THE STENT DISLODGED OUTSIDE THE PATIENT. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 14365953 ↗
• MalfunctionNov 27, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE BIFURCATION OF THE ILIAC TWO DIFFERENT OMNILINK STENT DELIVERY SYSTEMS LEAKED AT THE HUB WHEN INFLATION WAS ATTEMPTED. THE CONNECTIONS WERE CHECKED, BUT DID NOT RESOLVE THE LEAK. THE STENTS WERE NOT DEPLOYED AND WERE REMOVED WITHOUT ISSUE. A THIRD OMNILINK STENT SYSTEM WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061199 ↗
• MalfunctionJul 21, 2017Unstable

  REPORTEDLY, A 10X39MM OTW OMNILINK ELITE BALLOON-EXPANDABLE STENT SYSTEM WAS REMOVED FROM THE DISPENSER COIL; HOWEVER, IT WAS NOTICED THAT THE STENT WAS LOOSE. NO RESISTANCE REMOVING THE DEVICE FROM THE DISPENSER COIL WAS FELT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OTW OMNILINK ELITE BALLOON-EXPANDABLE STENT SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6734172 ↗
• InjuryJun 5, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NON-ABBOTT STENT GRAFT WAS IMPLANTED IN THE ABDOMINAL AORTIC ANEURYSM. THE STENT GRAFT WAS NOT FULLY INFLATED AND PART OF THE GRAFT BENT. THE 10X39 MM OMNILINK ELITE STENT WAS INSERTED THROUGH THE RADIAL ACCESS SITE INTO THE STENT GRAFT TO REINFORCE THE GRAFT, BUT THE OMNILINK STENT DISLODGED FROM THE DELIVERY SYSTEM DURING POSITIONING. THE OMNILINK ELITE STENT WAS DEPLOYED AT AN UNINTENDED VESSEL IN THE EXTERNAL ILIAC ARTERY (EIA) USING A NON-ABBOTT BALLOON THROUGH A FEMORAL ACCESS SITE. ANOTHER STENT WAS IMPLANTED INSIDE THE STENT GRAFT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT EFFECT CAUSED BY THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6613548 ↗