Omnilink Elite 1012631-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648178504), received between Apr 13, 2017 and May 22, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LEFT COMMON ILIAC ARTERY. THE 8.0 X29MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCING OVER AN UNSPECIFIED SUPRACORE GUIDE WIRE AND PRIOR TO BEING INSERTED INTO THE SHEATH BEFORE ENTERING THE ROTATING HEMOSTASIS VALVE THE STENT DISLODGED STILL OUTSIDE OF THE PATIENT. ANOTHER OMNILINK ELITE STENT WAS USED TO SUCCESSFULLY COMPLETE 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 23284196 ↗
• MalfunctionNov 29, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING UNPACKAGING, THE INNER PACKAGE OF THE 8X29MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS NOT SEALED, THUS ALLOWING AIR TO FREELY FLOW. NO DAMAGE NOTED TO THE DEVICE OR CHIPBOARD BOX. A NEW OMNILINK STENT 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 20810765 ↗
• MalfunctionMay 31, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE 8.0X29MM OTW OMNILINK ELITE BALLOON WAS PREPPED PRIOR TO REMOVAL OF THE PROTECTIVE SHEATH; HOWEVER RESISTANCE WAS THEN MET WHEN ATTEMPTING TO REMOVE THE SHEATH. WHEN THE PROTECTIVE SHEATH WAS ABLE TO BE REMOVED, THE STENT CAME OFF THE BALLOON. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-ABBOTT DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436285 ↗
• InjuryJan 3, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. DURING ADVANCEMENT OF THE 8.0X29MM OMNI ELITE PERIPHERAL STENT SYSTEM USING A 6F SHEATH, RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT BECAME DISLODGED IN THE DISTAL TIBIAL ARTERY. THE STENT REMAINED ON THE GUIDE WIRE AND A SMALL BALLOON WAS USED TO DEPLOY THE OMNI ELITE STENT IN THE TIBIAL ARTERY IN HEALTHY TISSUE. ANOTHER OMNI ELITE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18438821 ↗
• MalfunctionDec 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 8.0X29MM OMNILINK ELITE STENT IT WAS NOTED THE STENT DISLODGED. THE DEVICE WAS NOT USED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906395 ↗
• MalfunctionOct 17, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH 70% STENOSIS. THE 8.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A .035 GUIDEWIRE THROUGH A STANDARD 6 FRENCH (FR) SHEATH, UTILIZING THE LEFT ANTERIOR TIBIAL FOR ACCESS. AS THE DISTAL END OF THE SDS WAS ADVANCED TO THE PROXIMAL PORTION OF THE LEFT ANTERIOR TIBIAL, IT WOULD NOT ADVANCE THROUGH THE SEVERE CALCIFICATION. THE DEVICE WAS THEN ATTEMPTED TO BE REMOVED BUT GOT CAUGHT ON THE DISTAL END OF THE SHEATH. THE SDS AND THE SHEATH WERE REMOVED AS A UNIT. WIRE ACCESS WAS MAINTAINED AS THE CATHETER AND SHEATH WERE SUCCESSFULLY REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS TERMINATED AND NO OTHER INTERVENTION WAS ATTEMPTED FOR THE ILIAC LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615579 ↗
• InjuryAug 3, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT COMMON ILIAC ARTERY. THE 8.0X29MM OMNILINK ELITE STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE WITH ANATOMY BEFORE REACHING THE TARGET LESION AND THE STENT DISLODGED. THE STENT WAS REMOVED VIA SNARE. FURTHER DILATATION WAS PERFORMED AND A NEW OMNILINK STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160204 ↗
• InjuryAug 19, 2021Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT COMMON ILIAC ARTERY THAT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE OMNILINK STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING DEPLOYMENT, THE BALLOON RUPTURED AT 7 ATMOSPHERES. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND AN ARMADA 35 WAS USED TO FULLY EXPAND AND OPEN THE STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345667 ↗
• MalfunctionSep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE 8X29MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (BES) WAS REMOVED FROM THE PACKAGING AND AFTER REMOVAL OF THE PROTECTIVE SHEATH, THE END OF THE STENT WAS LOOSE ON THE BALLOON. THE BES WAS DISCARDED, AND ANOTHER DEVICE 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 Patient Involvement

  MAUDE report 10551559 ↗
• MalfunctionApr 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE ADVANCING THE OMNILINK STENT DELIVERY SYSTEM, THE STENT DISLODGED FROM BALLOON. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW OMNILINK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9949961 ↗
• MalfunctionJun 3, 2019Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ILIAC ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. A 6F NON-ABBOTT SHEATH WAS PLACED. FOLLOWING THE SUCCESSFUL DEPLOYMENT OF AN UNSPECIFIED STENT, A 8.0 X 29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, MET RESISTANCE WITH THE DEPLOYED STENT AND THE STENT STRUTS FLARED. THE STENT REMAINED ON THE SDS. THE SDS WAS ATTEMPTED TO BE REMOVED BUT RESISTANCE WITH THE SHEATH WAS MET. THE SDS AND THE SHEATH WERE THEREFORE REMOVED TOGETHER AS A SINGLE UNIT. THERE WAS NO REPORTED DAMAGE TO THE IMPLANTED STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW SHEATH AND A NEW UNSPECIFIED SDS. 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 8664374 ↗
• InjuryOct 25, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CALCIFIED, RIGHT ILIAC ARTERY THE 8 X 29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE 6 FR NON-ABBOTT SHEATH BUT MET RESISTANCE AND BECAME STUCK. THE SDS COULD NOT BE ADVANCED OR REMOVED SEPARATELY; ALL DEVICES WERE BEING REMOVED FROM THE ANATOMY AS A SYSTEM WHEN THE STENT IMPLANT DISLODGED OFF THE BALLOON INTO THE ANATOMY. A CUTDOWN PROCEDURE WAS USED TO SUCCESSFULLY REMOVE THE STENT FROM THE ANATOMY WITHOUT ADVERSE PATIENT SEQUELA. A DIFFERENT STENT WAS USED IN THE PROCEDURE WITHOUT ISSUE. THE PATIENT WAS REPORTED IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005227 ↗
• MalfunctionSep 13, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE COMMON ILIAC, MODERATELY CALCIFIED LESION WITHOUT ISSUE. BALLOON INFLATION WAS ATTEMPTED, HOWEVER, THE BALLOON FAILED TO INFLATE. THE SDS WITH THE UNDEPLOYED STENT WAS REMOVED WITHOUT ISSUE. THE STENT REMAINED ON THE DELIVERY SYSTEM WITH NO DISLODGMENT AND NO MOVEMENT NOTED. THE DEVICE WAS DISCARDED AND ANOTHER OMNILINK WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873079 ↗
• MalfunctionMay 3, 2017Difficult To Position; Unstable; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE COMMON ILIAC ARTERY (CIA) WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 90% STENOSED. RESISTANCE WAS FELT WITH THE ANATOMY AND OTHER DEVICE [GUIDE CATHETER] DURING THE ADVANCEMENT OF A 8.0 X 19 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) TO THE LESION AND IT WOULD NOT CROSS IT. DURING THE ATTEMPT TO CROSS, THE SDS WAS PUSHED AND PULLED RESULTING IN FLARED STRUTS ON THE STENT IMPLANT. THE DEVICE WAS REMOVED FROM THE ANATOMY. A NEW OMNILINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS INDICATED THAT THE STENT MOVED DISTALLY FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540994 ↗
• InjuryApr 13, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED 90% STENOSED LEFT COMMON ILIAC ARTERY. FOLLOWING THE SUCCESSFUL DEPLOYMENT OF AN 8.0 X 29 MM OMNI ELITE VASCULAR STENT THE PHYSICIAN DECIDED TO DEPLOY ANOTHER 8.0 X 29 MM OTW OMNI ELITE VASCULAR STENT PROXIMALLY. THE OMNI ELITE VASCULAR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DURING DEPLOYMENT THE STENT IMPLANT DISLODGED FROM THE BALLOON. THE SDS WAS REMOVED FROM THE ANATOMY. THE 6F NON-ABBOTT INTRODUCER SHEATH WAS REPLACED WITH AN 8F NON-ABBOTT INTRODUCER SHEATH AND A SNARE DEVICE WAS USED TO RETRIEVE THE STENT IMPLANT. THE PROCEDURE WAS STOPPED AT THAT POINT AND THEY HAD TO HOLD ADDITIONAL PRESSURE ON THE ACCESS SITE TO STOP THE BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488950 ↗