Omnilink Elite 1012631-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648178498), received between Mar 29, 2017 and Mar 14, 2025 — classified as 3 injuries, 8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO FILING THE INITIAL MDR, THE FOLLOWING INFORMATION WAS RECEIVED WHICH CLARIFIED HOW THE DISLODGED STENT WAS REMOVED FROM THE PATIENT ANATOMY: THE BALLOON EXPANDABLE STENT WAS REMOVED ALONG WITH THE DELIVERY CATHETER AS A SINGLE UNIT INSTEAD OF THE INITIAL REPORT THAT THE DISLODGED STENT WAS SNARED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606163 ↗
• MalfunctionOct 3, 2024Improper 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 PERFORMED TO TREAT A LESION IN THE UNKNOWN LESION. A 8X19MM OMNI LINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED INTO THE ANATOMY HOWEVER, THE STENT WAS NOT LOCATED ON THE BALLOON. THE BES WAS REMOVED AND THE STENT WAS FOUND TO BE ON THE PREPARATION TABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358145 ↗
• InjurySep 30, 2024Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE LEFT EXTERNAL ILIAC ARTERY AND THE RIGHT EXTERNAL ILIAC ARTERY. A 7.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT WAS IMPLANTED FIRST WITHOUT ISSUE IN THE LEFT EXTERNAL ILIAC ARTERY. THEN AN 8.0MM/19MM/OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO BE ADVANCED TO THE RIGHT EXTERNAL ILIAC ARTERY. HOWEVER, THE PHYSICIAN DID NOT LIKE THE ANGLE OF THE VESSEL AND DECIDED TO RETRACT AND READVANCE THE BESS THROUGH THE EXTERNAL ILIAC ARTERY. THE BESS WAS ADVANCED THROUGH THE ABSOLUTE PRO IMPLANTED DISTAL STENT. RESISTANCE MET WITH THE ANATOMY WHEN POSITIONING THE BESS IN THE ARTERY AND THE PHYSICIAN APPLIED FORCE TO TURN THE BESS. A DECISION WAS MADE TO REMOVE THE BESS DUE TO THE RESISTANCE. THE BESS WAS REMOVED WITHOUT DIFFICULTY. HOWEVER, THE STENT WAS DISCOVERED MISSING. ANGIOGRAPHY WAS PERFORMED AND THE STENT WAS FOUND STUCK IN THE MIDDLE PORTION OF THE IMPLANTED ABSOLUTE PRO STENT. A 014 NON-ABBOTT GUIDEWIRE AND AN UNSPECIFIED BALLOON CATHETER WERE ADVANCED TO DEPLOY THE DETACHED STENT. THE STENT WAS DEPLOYED INSIDE THE PREVIOUSLY IMPLANTED STENT. NO DAMAGED NOTED ON THE ABSOLUTE PRO STENT. ANOTHER OTW O

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20338521 ↗
• MalfunctionMar 6, 2024Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A COMMON ILIAC ARTERY LESION. A 8.0×19MM OMNILINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BES) WAS DELIVERED TO THE TARGET LESION; HOWEVER, WHEN AIR ASPIRATION WAS PERFORMED, MORE AIR WAS ASPIRATED THAN USUAL. IT WAS SUSPECTED THAT THE BES COULD HAVE A LEAK; THEREFORE, THE BES WAS REMOVED. ANOTHER OMNILINK ELITE WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18846161 ↗
• MalfunctionMar 13, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED NON-TORTUOUS RIGHT SUBCLAVIAN ARTERY. THE 8.0X19MM OMNILINK ELITE STENT DELIVERY CATHETER FAILED TO CROSS DUE TO THE ANATOMY AND DURING REMOVAL OF THE DEVICE, THE STENT DISLODGED OUTSIDE OF THE PATIENT WHILE AT THE HUB OF THE UNSPECIFIED SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 8X17MM NON-ABBOTT STENT. 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 9831834 ↗
• MalfunctionMay 9, 2019Off-Label Use; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A STENOSED LESION IN THE LEFT SUBCLAVIAN WITH HEAVY CALCIFICATION. A 8.0 X 19 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. ON REMOVAL OF THE SDS WITH NO REPORTED RESISTANCE, THE STENT DISLODGED AT THE SITE OF THE UNSPECIFIED TOUHY BLEED BACK CONTROL VALVE. THE STENT WAS THEREFORE SIMPLY MANUALLY REMOVED AND A NEW UNSPECIFIED OMNILINK ELITE SDS WAS ADVANCED SUCCESSFULLY TO 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 8597429 ↗
• MalfunctionDec 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE RIGHT ILIAC ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. AN 8.0X19MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED WITHOUT RESISTANCE. THE STENT ADVANCED SLIGHTLY BEYOND THE TARGET LESION, AND WHEN THE SDS WAS PULLED BACK TO POSITION THE STENT IN THE TARGET LESION, THE STENT BEGAN TO COME OFF THE BALLOON. THE BALLOON WAS THEN INFLATED TO 16 ATMOSPHERES TO DEPLOY THE STENT PARTIALLY WITHIN THE TARGET LESION. THE PROCEDURE WAS CONCLUDED AFTER THE OMNILINK STENT WAS DEPLOYED WITHOUT ANY FURTHER TREATMENT OF THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122696 ↗
• InjurySep 7, 2018Improper 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 THIS WAS A PERCUTANEOUS INTERVENTION TREATING A TORTUOUS ILIAC VESSEL WITH MODERATE CALCIFICATION. THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) ATTEMPTED TO CROSS THE MODERATELY CALCIFIED LESION, HOWEVER, WOULD NOT ADVANCE DUE TO ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PATIENT WAS RE-WIRED WITH A STIFFER WIRE. THE SAME OMNILINK ELITE SDS WAS RE-INSERTED AND AGAIN FAILED TO CROSS THE LESION DUE TO ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND BALLOON ANGIOPLASTY WAS PERFORMED AT THE LESION SITE. THE SAME OMNILINK ELITE SDS WAS RE-INSERTED FOR A THIRD TIME, AND AGAIN FAILED TO CROSS THE LESION. DURING SDS REMOVAL, THE STENT DISLODGED FROM THE SDS, DUE TO ANATOMY, IN A COMPLETELY UNINTENDED AREA, THE MID ILIAC. AS TREATMENT, ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED WITHIN THE STENT, APPOSING THE STENT TO THE VESSEL WALL. ANOTHER DEVICE WAS USED TO TREAT THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7856934 ↗
• MalfunctionMay 14, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED, RIGHT EXTERNAL ILIAC ARTERY WITH AN 8.0 X 19 MM OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM (SDS). REPORTEDLY, THE SDS WAS ADVANCED TO THE LESION AND THEN THE PHYSICIAN WAS CALLED OUT OF THE ROOM TO ATTEND TO AN EMERGENCY. IT WAS INITIALLY DECIDED TO WAIT FOR THE PHYSICIAN TO RETURN PRIOR TO PROCEEDING WITH THE PROCEDURE. THEN THE DECISION WAS MADE TO REMOVE THE SDS FROM THE ANATOMY. DURING REMOVAL, THE STENT IMPLANT DISLODGED FROM THE BALLOON IN THE VICINITY OF THE COMMON ILIAC, BUT REMAINED ON THE UNSPECIFIED GUIDE WIRE. THE SDS WAS ADVANCED, RE-CAPTURED THE STENT AND THE STENT WAS DEPLOYED PARTIALLY WITHIN THE TARGET LESION. A NEW UNSPECIFIED SDS WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED OVERLAPPING THE DISTAL END OF THE OMNILINK ELITE STENT BY 2 TO 3 MM TO 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 7511142 ↗
• MalfunctionFeb 28, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT AND RIGHT ILIAC ARTERIES WITH A KISSING STENT TECHNIQUE AT THE BIFURCATION. THE 8.0X19MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RIGHT ILIAC WHILE ANOTHER SDS WAS ADVANCED TO THE LEFT ILIAC SIMULTANEOUSLY. ONCE THE OMNILINK ELITE SDS WAS PLACED IN THE TARGET LESION, IT WAS NOTED THE STENT WAS NOT ON THE BALLOON, BUT HAD DISLODGED PROXIMALLY ONTO THE SHAFT. NEGATIVE WAS PULLED ON THE BALLOON AND THE SDS WAS RETRACTED UNTIL THE STENT WAS OVER THE BALLOON. THE SDS WAS THEN ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED SUCCESSFULLY. THE PHYSICIAN STATED HE DID NOT KNOW WHETHER THE STENT CAUGHT ON THE 6FR SHEATH OR INTERACTED WITH THE ANATOMY DURING ADVANCEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304687 ↗
• InjuryMar 29, 2017Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSIS IN THE LEFT COMMON ILIAC WITH MILD TORTUOSITY AND MILD CALCIFICATION USING A RADIAL APPROACH. A 6F GUIDING SHEATH WAS USED AND PRE-DILATATION WAS PERFORMED WITH 6.0 X 40 MM BALLOON. THE 8.0 X 19 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND INFLATED SLOWLY FROM 4 ATMOSPHERES (ATM) TO 14 ATM, BUT AN INDENTATION WAS NOTED IN THE BALLOON. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, BUT IT WOULD NOT DEFLATE AT ALL; THEREFORE, THE BALLOON WAS INFLATED SLOWLY TO 18 ATM AND THE BALLOON INDENTATION RESOLVED AND THE STENT WAS FULLY EXPANDED. THE BALLOON STILL WOULD NOT DEFLATE SO THE SHEATH WAS MOVED TO THE BALLOON AND REPEATED ATTEMPTS TO DEFLATE WERE STILL UNSUCCESSFUL. A 7F GUIDING CATHETER WAS USED FROM THE LEFT FEMORAL AND A SNARE DEVICE CAPTURED THE GUIDE WIRE AND WAS REMOVED FROM THE FEMORAL. A 7F GUIDELINER AND A 4.0 X 40 MM BALLOON WERE ADVANCED FROM THE FEMORAL TO RETRIEVE THE OMNILINK ELITE SDS, BUT FAILED. AN ATTEMPT WAS MADE TO RUPTURE THE BALLOON USING A GUIDE WIRE, BUT THE BALLOON WOULD NOT RUPTURE. A SNARE WAS USED TO PULL THE INFLATED BALLOON TO THE FEMORAL PUNCTURE SITE, BUT THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6443597 ↗