Omnilink Elite 1012624-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648179297), received between May 30, 2017 and Nov 26, 2025 — classified as 5 injuries, 6 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.

• InjuryNov 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH AN ARTICLE OF AN INDIVIDUAL CASE REGARDING A PATIENT PRESENTED WITH A LEFT LEG INTERMITTENT CLAUDICATION WITH SEVERE CALCIFIED STENOSIS OF THE LEFT COMMON ILIAC ARTERY (CIA) AND THROMBOTIC OCCLUSION OF THE LEFT EXTERNAL ILIAC ARTERY ON (B)(6) 2024. THEREFORE, THROMBECTOMY WAS PERFORMED AND TWO OMNILINK ELITE STENTS (8.0X29MM / 8.0X39MM) WERE PLACED IN THE CIA. COMPUTED TOMOGRAPHY (CT) WAS OBTAINED ON POSTPROCEDURAL DAY 4 BECAUSE THE LEFT ANKLE-BRACHIAL PRESSURE INDEX (ABI) REMAINED LOW AT 0.85 COMPARED WITH 1.07 ON THE RIGHT. CT REVEALED THE OMNILINK STENTS HAD COLLAPSED WITHIN THE CIA AND IN-STENT STENOSIS WAS PRESENT. ON DAY 7 BALLOON ANGIOPLASTY WAS PERFORMED WITH ADDITIONAL PLACEMENT OF A NON-ABBOTT SELF-EXPANDING STENT. POSTPROCEDURAL CT CONFIRMED SATISFACTORY STENT EXPANSION. HOWEVER, ON (B)(6) 2024, CT OBTAINED FOR EVALUATION OF GASTROINTESTINAL BLEEDING AGAIN SHOWED STENT COLLAPSE WITHIN THE CIA. PER THE PHYSICIAN'S OPINION THE BLEEDING WAS NOT CAUSE BY THE OMNILINK STENTS. FLUOROSCOPY DEMONSTRATED SEVERE STENT COLLAPSE AT THE HEAVILY CALCIFIED SEGMENT. PRE-DILATATION WAS PERFORMED WITH A 7.0 MM NON-ABBOTT BALLOON AND A 7.5X60MM SUPERA SELF-EXPANDING

  Patient problems: Stenosis

  MAUDE report 23662657 ↗
• MalfunctionJun 25, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A 8.0MM/29MM/80MM OTW OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (BES) THE PROTECTIVE SHEATH WAS NOT REMOVED PRIOR TO PREPARATION. AFTER REMOVAL OF THE PROTECTIVE SHEATH, THE STENT WAS NOTED TO BE OUT OF PLACE. ANOTHER OMNILINK STENT WAS USED AND THE PROCEDURE WAS COMPLETED. 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 19604103 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A LESION IN THE LEFT COMMON ILIAC ARTERY. DURING ADVANCEMENT OF THE 8X29MM OMNILINK BALLOON EXPANDING STENT BES, WHEN THE BES HAD JUST PASSED THE 6F SHEATH THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE; HOWEVER, A 4MM BALLOON WAS USED TO IMPLANT THE STENT IN HEALTHY TISSUE IN THE EXTERNAL ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19559342 ↗
• MalfunctionJun 9, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE STENT WAS REMOVED FROM THE PATIENT ANATOMY ON THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100608 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, AN OMNILINK STENT WAS IMPLANTED WITHOUT ISSUE. APPROXIMATELY 6 MONTHS AFTER STENT IMPLANTATION, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS, WITHOUT SKIN CHANGES, AND CONTINUED TO HAVE RECURRENT SYMPTOMS AT UNSPECIFIED TIMES. REPORTEDLY, THE PATIENT HAD SEVERAL IMPLANTS AFTER THE OMNILINK WAS IMPLANTED. THE PATIENT IS BEING SEEN FOR A POSSIBLE ALLERGIC REACTION, BUT THE TEST HAS NOT YET BEEN PERFORMED AND A TREATMENT PLAN HAS NOT YET BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13425866 ↗
• MalfunctionApr 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER UNPACKING THE 8.0X29MM OMNI ELITE BALLOON-EXPANDABLE STENT (BES), IT WAS NOTED THAT THE STENT LOOKED LOOSE ON THE BALLOON. THE DEVICE WAS NOT USED FOR 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 11704307 ↗
• MalfunctionFeb 19, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND BEFORE USE, RESISTANCE WAS MET WHEN REMOVING THE PROTECTIVE SHEATH FROM THE STENT AND THE STENT DISLODGED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. TWO ADDITIONAL OMNILINK STENTS WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11355578 ↗
• MalfunctionDec 7, 2020Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC, HEAVILY CALCIFIED, MODERATELY TORTUOUS, DE NOVO SUPERIOR MESENTERIC ARTERY (SMA). AN 8X29MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (BES) WAS ADVANCED THROUGH THE GUIDE CATHETER, BUT AS IT WAS EXITING THE GUIDE CATHETER INTO THE VESSEL, RESISTANCE WAS NOTED AND ANGIOGRAPHY CONFIRMED THE STENT WAS LOOSE ON THE BALLOON. DUE TO THE POSSIBILITY OF A STENT DISLODGEMENT, THE BALLOON WAS SLIGHTLY INFLATED TO HOLD THE STENT, AND THE STENT AND THE GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 7X29MM OMNILINK BES WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10961783 ↗
• MalfunctionDec 17, 2018Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE 8.0MMX29MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED PROXIMALLY TO A PREVIOUSLY IMPLANTED SELF-EXPANDING STENT. RESISTANCE WAS FELT AS THE STENT ENTERED THE TARGET LESION ZONE, AND THE STENT DISLODGED FROM THE SDS. THE STENT BACKED UP OFF THE BALLOON AND STAYED ON THE STENT/BALLOON DELIVERY CATHETER. THE CATHETER WAS WITHDRAWN WITH THE STENT STILL ON THE SHAFT. NO SNARE OR ADDITIONAL DEVICE WAS NEEDED FOR RETRIEVAL. A NEW, SAME SIZE OMNILINK ELITE 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 Consequences Or Impact To Patient

  MAUDE report 8171419 ↗
• InjurySep 7, 2018Device Damaged by Another Device; Difficult to Advance; Material Deformation; Migration; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT COMMON ILIAC ARTERY. THE 8.0 X 29 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. THE STENT WAS WELL APPOSED TO THE VESSEL WALL AND EVERYTHING LOOKED GOOD. THE PHYSICIAN DECIDED TO ADVANCE A SHEATH THROUGH THE NEWLY IMPLANTED STENT, TO EVALUATE THE DISTAL VESSEL FOR ADDITIONAL LESIONS/INTERVENTION. THE SHEATH HAD RESISTANCE ADVANCING THROUGH THE STENT AND CAUSED THE STENT TO BUCKLE AND MOVE FROM ITS ORIGINAL POSITION. THE SHEATH WAS REMOVED AND A DILATATION CATHETER WAS ADVANCED. ADDITIONAL BALLOONING WAS ABLE TO TREAT THE BUCKLING. AS THE STENT HAD MOVED FROM ITS ORIGINAL LOCATION, AN ADDITIONAL 8.0 X 29 MM OMNILINK ELITE STENT WAS IMPLANTED AT THE PROXIMAL LESION TO COVER THE LESION THAT WAS UNCOVERED WHEN THE STENT MOVED. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856544 ↗
• InjuryMay 30, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT LESIONS IN THE LEFT AND RIGHT COMMON ILIAC ARTERIES. AN 8X29MM OMNILINK ELITE STENT AND A SECOND UNKNOWN OMNILINK ELITE STENT WERE IMPLANTED IN THE BIFURCATION. THE PATIENT WAS READMITTED ON (B)(6) 2017. ABOUT ONE THIRD OF THE 8X29MM STENT IMPLANTED ON THE RIGHT SIDE OF THE BIFURCATION BROKE OFF AND MIGRATED TO THE DISTAL RIGHT EXTERNAL ARTERY. AN ABSOLUTE PRO STENT WAS IMPLANTED TO JAIL THE BROKEN PIECE AGAINST THE ARTERY WALL. POST-DILATATION WAS PERFORMED WITH A 7.0X60MM ARMADA 35 BALLOON CATHETER SUCCESSFULLY. 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 6599849 ↗