Omnilink Elite 1012625-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648179341), received between Apr 27, 2017 and Aug 11, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 9.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGING THE STENT DISLODGED FROM THE BALLOON WHEN REMOVING THE PROTECTIVE SHEATH AND STYLET. ANOTHER SAME SIZE DEVICE WAS USED TO 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 22773245 ↗
• InjuryDec 6, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 9.0X39MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED INTO A 7F NON-ABBOTT GUIDING SHEATH WHEN THE BES MET RESISTANCE WITH THE TIP OF THE SHEATH CAUSING THE STENT TO DISLODGE. AFTER REMOVAL OF THE DELIVERY CATHETER, THE STENT REMAINED UNEXPANDED WITH HALF OF THE STENT WAS IN THE GUIDING SHEATH AND THE OTHER HALF IN THE ILIAC ARTERY. THE STENT WAS SNARED OUT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. A NEW SAME SIZE OMNI ELITE BES WAS ADVANCED THROUGH AN 8F SHEATH SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926530 ↗
• MalfunctionJan 11, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ILIAC ARTERY. PRE-DILATATION WAS PERFORMED. AN OMNILINK STENT WAS ADVANCED TO THE LESION BUT ONCE THE BALLOON WAS INFLATED TO DEPLOY THE STENT, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED, STENT IMPLANT STILL ON THE OMNILINK. ON THE STERILE TABLE, THE BALLOON WAS ONCE AGAIN ATTEMPTED TO INFLATE, BUT FAILED COMPLETELY. ANOTHER SAME SIZE OMNILINK WAS USED 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 11151752 ↗
• InjuryOct 7, 2020Migration; Migration

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6) 2018, TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 9.0X39MM OMNILINK ELITE STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2020, A SECOND PROCEDURE WAS PERFORMED TO TREAT AN AORTIC ANEURYSM. IT WAS NOTED THE OMNILINK ELITE WAS NOT WHERE IT HAD BEEN DEPLOYED. THE STENT WAS NOTED IN THE AORTIC ANEURYSM. ANOTHER STENT WAS IMPLANTED, CRUSHING THE OMNILINK STENT AGAINST THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 10644373 ↗
• MalfunctionSep 9, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL PROCEDURE TO TREAT THE HEAVILY CALCIFIED ILIAC ARTERY. THE OMNILINK ELITE (OLE) STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE TO THE ILIAC, BUT THE SDS DID NOT INFLATE. AFTER REMOVAL, THE STENT WAS INTACT ON THE BALLOON SDS. ANOTHER OLE SDS WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508655 ↗
• InjuryMay 22, 2018Device Damaged by Another Device

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL INTERVENTION TO TREAT THE HEAVILY CALCIFIED ILIAC ARTERIES. DURING ADVANCEMENT OF THE 9.0X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) THROUGH A 6 FRENCH SHEATH IT WAS NOTED THAT THE SDS WAS ADVANCED TOO FAR INTO THE AORTA. WHEN THE SDS WAS PULLED BACK TO POSITION IN THE ILIAC, THE STENT DISLODGED FROM THE SDS BUT REMAINED ON THE GUIDE WIRE. THE PROCEDURE CONTINUED WITH DEPLOYMENT OF THE 9.0X39 OMNILINK ELITE STENT IN THE ILIAC ARTERY. THE INTRODUCER SHEATH WAS UP-SIZED TO A 7 FRENCH SHEATH AND A SNARE WAS INSERTED. THE DISLODGED STENT WAS PULLED BACK WITH THE SNARE; HOWEVER, IT INTERACTED WITH THE DEPLOYED 9.0X39 OMNILINK ELITE STENT. THE SNARE WAS REMOVED AND THE STENT WAS RE-SNARED, BUT DURING RETRACTION, IT INTERACTED WITH THE DEPLOYED STENT AGAIN. THIS TIME, THE DEVICES BECAME STUCK AND THE GROIN ACCESS SITE WAS BLEEDING, POSSIBLY FROM MANIPULATION OF THE DEVICES. OXYGEN SATURATION WAS DECREASED FROM THE BLOOD LOSS. PRESSURE WAS HELD ON THE GROIN SITE AND THE PROCEDURE WAS STOPPED. SURGERY WAS PERFORMED TO REMOVE THE STUCK DEVICES (DISLODGED STENT, SNARE, DEPLOYED STENT) AND PERFORM A PATCH ANGIOPLASTY PROCEDURE TO TREAT THE VESSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7534336 ↗
• InjuryApr 2, 2018Migration or Expulsion of Device

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT BI-LATERAL LESIONS IN THE COMMON ILIAC VESSEL. THERE WAS NO TORTUOSITY AND NO CALCIFICATION ON THE LEFT SIDE AND CALCIFICATION OF THE RIGHT SIDE. TWO OMNI ELITE STENTS WERE PLANNED FOR A KISSING STENT TECHNIQUE. ONE STENT WAS IMPLANTED IN THE RIGHT COMMON ILIAC WITHOUT ISSUE. THE 9.0 X 39 MM OMNI ELITE STENT WAS THEN IMPLANTED IN THE LEFT COMMON ILIAC WITH A GOOD RESULT. AFTER THE RIGHT SIDE WAS CLOSED, A GUIDE WIRE WAS ADVANCED TO CLOSE THE LEFT SIDE; HOWEVER, IT WAS OBSERVED THAT THE STENT ON THE LEFT SIDE HAD COMPLETELY MIGRATED OUT OF THE TARGET LESION. AN ADDITIONAL OMNI ELITE STENT WAS IMPLANTED TO SECURE THE MIGRATED STENT. THE PHYSICIAN COMMENTED THAT THE STENTS MAY NOT HAVE BEEN PLACED KISSING, AND THE FLOW MAY HAVE PUSHED THE STENT OUT OF THE LESION. THE PATIENT WAS CONFIRMED TO BE STABLE POST PROCEDURE AND NO FURTHER TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7388909 ↗
• InjuryMar 1, 2018Difficult To Position; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 9X39MM OMNI ELITE STENT WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY; HOWEVER, A SHEATH WAS BEING ADVANCED THROUGH THE STENT TO OBTAIN LEFT ACCESS AND THE SHEATH BECAME STUCK WITH THE STENT. THE STENT MIGRATED AND ELONGATED TOWARDS THE LEFT COMMON ILIAC ARTERY AND AORTA BIFURCATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING TWO UNKNOWN KISSING STENTS TO SMASH THE OMNILINK ELITE STENT AGAINST THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7308279 ↗
• MalfunctionApr 27, 2017Unstable

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT COMMON ILIAC ARTERY. WHEN THE OVER THE WIRE OMNI ELITE 9.0 MM/39 MM/80 CM STENT WAS OPENED, THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER OMNI LINK STENT WAS USED AS REPLACEMENT. WHEN THE ARMADA 14 PTA BALLOON CATHETER WAS BEING USED FOR DILATATION THE BALLOON RUPTURED BELOW RATED BURST PRESSURE. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND ANOTHER ARMADA 14 BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6528597 ↗