Omnilink Elite 1012625-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648179334), received between Jan 19, 2017 and Jun 26, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 17, 2024Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENTLY, AFTER THE INITIAL REPORTED WAS FILED IT WAS NOTED THAT THE STENT BECAME STUCK WITH THE PREVIOUSLY IMPLANTED AND DISLODGED. THE STENT HAD TO BE SNARED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126872 ↗
• MalfunctionFeb 8, 2024Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE SUBCLAVIAN ARTERY. THE 9.0X29MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND AIR ASPIRATION PERFORMED; HOWEVER MORE AIR THAN USUAL WAS NOTED THEREFORE A LEAK WAS SUSPECTED. THE SDS WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED USING ANOTHER OMNILINK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666988 ↗
• MalfunctionApr 6, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN EXTERNAL ILIAC ARTERY. THE 9.0X29MM OMNILINK ELITE STENT WAS ADVANCED THROUGH A 6FR SHEATH; HOWEVER, RESISTANCE WAS FELT AND THE DEVICE BECAME STUCK. THE DEVICE WAS ABLE TO BE REMOVED SEPARATELY, BUT RESISTANCE WAS STILL FELT WITH THE SHEATH. AN ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE SAME 6FR SHEATH. THERE WAS 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 16694284 ↗
• InjuryJul 29, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS BEING PERFORMED ON THE MODERATELY TORTUOUS LEFT ILIAC ARTERY WITH MODERATE CALCIFICATION. THE OMNILINK ELITE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE ANATOMY. THE DEVICE WAS REMOVED WITHOUT UNUSUAL RESISTANCE NOTED WHEN THE STENT HAD DISLODGED OFF THE DELIVERY SYSTEM, WHILE REMAINING ON THE GUIDE WIRE. AS INTERVENTION, PRESSURE WAS HELD PROXIMAL TO THE DISLODGED STENT USING THE BALLOON CATHETER AND A 6 FRENCH SHEATH ADVANCED. THE DISLODGED STENT STRUTS CAUGHT THE OUTSIDE EDGE OF THE SHEATH AND ALL WAS REMOVED FROM THE ANATOMY. ANOTHER SIZED STENT WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246749 ↗
• InjuryMay 18, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING THE PROXIMAL RIGHT COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS WAS OBTAINED IN BOTH THE RIGHT RADIAL AND RIGHT PEDAL. THE SFA WAS TREATED VIA PEDAL ACCESS. USING THE RADIAL ACCESS, A 9X29MM OMNILINK ELITE OTW ADVANCED WITHOUT ISSUES TO THE ILIAC ARTERY, TREATMENT SITE. THE OPERATOR HAD THEN MOVED THE DEVICE INADVERTENTLY. BEFORE DEPLOYMENT AND WITHOUT RE-ASSESSING THROUGH IMAGING WHERE THE DEVICE WAS LOCATED AFTER THIS MOVEMENT, THE OMNILINK ELITE STENT WAS DEPLOYED. THERE WAS NO UNUSUAL RESISTANCE AND NO DEVICE MALFUNCTION OBSERVED. PER POST-DEPLOYMENT IMAGING, THE DEVICE HAD BEEN INADVERTENTLY DEPLOYED IN THE DISTAL AORTA. THIS WAS NOT A DEVICE ISSUE AND THERE WAS NO STENT MOVEMENT DURING OR POST-DEPLOYMENT, RATHER, THE DEVICE HAD BEEN MOVED BY THE OPERATOR BEFORE DEPLOYMENT AND THE LOCATION WAS NOT RE-ASSESSED PRIOR TO DEPLOYING. VIA RIGHT GROIN ACCESS AN ATTEMPT WAS MADE TO SNARE THE STENT WITH A 6 FRENCH (FR) AND 8FR SHEATH UNSUCCESSFULLY. AN 11 FR SHEATH WAS ABLE TO CAPTURE THE STENT SUCCESSFULLY AND REMOVED THE DEPLOYED STENT FROM THE ANATOMY WITHOUT INCIDENT. A NEW OMNILINK ELITE STENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841808 ↗
• MalfunctionSep 29, 2020Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD TORTUOSITY AND 90% STENOSIS IN THE RIGHT COMMON ILIAC ARTERY. A 9.0 X 29 MM OTW OMNI ELITE BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED TO THE TARGET LESION, HOWEVER, DURING THE BALLOON INFLATION, A LEAK WAS NOTED FROM THE CONNECTION BETWEEN THE HUB AND THE SHAFT. THEREFORE, THE PRESSURE COULD NOT BE APPLIED SMOOTHLY, AND THE STENT WAS DIFFICULT TO DEPLOY. WITH NOMINAL PRESSURE, THE STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602933 ↗
• MalfunctionJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ILIAC ARTERY. A 9.0X29MM OMNILINK ELITE BALLOON-EXPANDABLE STENT (BES) SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, BEFORE INFLATION, IT WAS NOTED THAT THE STENT MOVED (PARTIALLY DISLODGED) ON THE BALLOON, SO THE DEVICE, INCLUDING THE STENT WAS SUCCESSFULLY REMOVED FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SAME SIZE OMNILINK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353890 ↗
• MalfunctionJan 15, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ILIAC LESION. DURING PREPARATION OF THE OMNILINK ELITE, THE PHYSICIAN APPLIED NEGATIVE PRESSURE WITHOUT NOTICING THAT THE STENT FELL OFF. THE DEVICE WAS THEN INSERTED IN THE ANATOMY AND WHEN DEPLOYMENT WAS INITIATED, THE PHYSICIAN NOTED THAT THE STENT WAS NOT ON THE BALLOON, BUT HAD FALLEN OFF ON THE STERILE TABLE DURING PREP. ANOTHER UNSPECIFIED STENT 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 9591325 ↗
• InjuryJun 17, 2019Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUBCLAVIAN ARTERY. A 9.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL, THE STENT DISLODGED IN THE BRACHIAL ARTERY. AFTER MULTIPLE UNSPECIFIED MANEUVERS TO RETRIEVE THE STENT, THE PHYSICIAN USED A 3MM BALLOON TO DILATE THE DISLODGED STENT IN PLACE IN HEALTHY TISSUE. THE PROCEDURE WAS PROLONGED FOR AN ADDITIONAL 3 HOURS DUE TO THE DISLODGED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8704136 ↗
• MalfunctionMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED ILIAC ARTERY. DURING ADVANCEMENT OF A 9.0X29MM OMNILINK BALLOON EXPANDABLE STENT DELIVERY SYSTEM, THE STENT DISLODGED IN THE PROXIMAL END OF THE DISEASED TARGET VESSEL. THE STENT WAS DILATED WITH THE OMNILINK BALLOON TO STAY IN PLACE. THEN A 9.0X39MM OMNILINK STENT WAS ADVANCED THROUGH THE PREVIOUS OMNILINK TO THE DISTAL END OF THE TARGET LESION AND IMPLANTED. 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 8448313 ↗
• InjuryMay 22, 2018Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated

  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: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7534326 ↗
• MalfunctionNov 7, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A TARGET LESION IN THE COMMON ILIAC ARTERY, THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO ADVANCE THROUGH THE 6FRENCH NON-ABBOTT SHEATH. THE SDS COULD NOT BE REMOVED AND THE SDS AND SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008085 ↗
• MalfunctionFeb 17, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKAGING OF THE 9.0 MM X 29 MM X 80 CM OMNILINK ELITE, THE STENT DISLODGED FROM THE BALLOON AND WAS LOCATED INSIDE THE HOOP. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SAME SIZE OMNILINK ELITE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6341826 ↗
• MalfunctionJan 19, 2017Improper or Incorrect Procedure or Method; Physical Resistance; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. IT WAS A CONTRALATERAL APPROACH. A 9.0 X 29 MM OMNILINK ELITE STENT WAS DEPLOYED IN THE LESION. A SECOND 9.0 X 29 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS BEING ADVANCED THROUGH THE PREVIOUSLY PLACED STENT WHEN THERE WAS RESISTANCE WITH THE TIP AND THE DEPLOYED STENT, AND THE DEPLOYED STENT COMPRESSED APPROXIMATELY 10 MM AT THE PROXIMAL END. THE SECOND STENT WAS DEPLOYED DISTALLY TO THE FIRST STENT. A THIRD STENT WAS DEPLOYED PROXIMAL TO THE FIRST STENT TO COVER THE AREA WHERE THE STENT COMPRESSED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6265314 ↗