Omnilink Elite 1012630-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648178481), received between Aug 8, 2016 and Mar 30, 2026 — classified as 7 injuries, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Failure to Advance; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE 7.0X59MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AND EXPAND. 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 24712628 ↗
• MalfunctionOct 3, 2025Stretched; Improper or Incorrect Procedure or Method; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 7X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, WHEN PLACING THE STENT, THE STENT IMMEDIATELY BEGAN TO UNRAVEL [STRETCH]. THEREFORE, THE BES WAS REMOVED FROM THE PATIENT. IT WAS NOTED THAT AN EXPIRED PRODUCT WAS USED. A NON-ABBOTT STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213081 ↗
• MalfunctionOct 30, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 7X59 MM OMNILINK ELITE STENT WAS FRAYED OFF OF THE BALLOON [DISLODGED] AND GOT CAUGHT IN THE SHEATH. THE DEVICE WAS REMOVED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569362 ↗
• InjuryNov 10, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUBCLAVIAN ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 7.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE STENT DISLODGED FROM THE BALLOON. SURGERY WAS PERFORMED TO REMOVE THE DISLODGED STENT AND NOTHING REMAINS IN THE PATIENT. ANOTHER SAME SIZE OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUALAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113398 ↗
• MalfunctionAug 23, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 7.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION BUT THE PHYSICIAN DECIDED IT WAS TOO LONG. THERE WAS RESISTANCE WITH THE INTRODUCER SHEATH DURING REMOVAL AND THE STENT IMPLANT DISLODGED IN THE SHEATH. THE SHEATH AND SDS WERE WITHDRAWN TOGETHER AS ONE UNIT. THERE WAS NOTHING LEFT IN THE PATIENT ANATOMY. A NEW SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603176 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OSTIAL CIRCUMFLEX WITH MILD CALCIFICATION AND MILD TORTUOSITY. A 6FRENCHX23CM SHEATH WAS USED IN THE BRANCH ARTERY. THE 7.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT THE PHYSICIAN REALIZED A SHORTER LENGTH WAS NEEDED AND ATTEMPTED TO REMOVE THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE UPON REMOVAL, HOWEVER, THE STENT CAME OFF THE BALLOON. CUT DOWN SURGERY HAD TO BE PERFORMED TO HAVE THE STENT REMOVED FROM THE ARTERY. NOTHING WAS LEFT IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE. ALTHOUGH THERE WAS A REPORTED DELAY IN THE PROCEDURE, IT WAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS; THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599436 ↗
• InjuryAug 18, 2023Stretched; Device Damaged by Another Device; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2023, TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 60% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY. A 7.0MMX59MMX135CM OMNI ELITE BALLOON-EXPANDABLE STENT (BES) WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2023, THE PATIENT RETURNED FOR A PLANNED PROCEDURE TO FIX THE RIGHT SFA. ACCESS WAS GAINED FROM THE LEFT SIDE AND A NON-ABBOTT GUIDE WIRE WAS THEN ADVANCED, BUT INADVERTENTLY AND UNKNOWINGLY WENT THROUGH THE STENT STRUT OF THE PREVIOUSLY IMPLANTED OMNI ELITE STENT. THEN, A 6F NON-ABBOTT SHEATH WAS ADVANCED OVER THE GUIDE WIRE, HOWEVER, THE TIP OF THE SHEATH BECAME CAUGHT ON THE IMPLANTED OMNI ELITE STENT STRUT AND ELONGATED THE IMPLANTED STENT A LARGE DISTANCE IN THE VESSEL, HOWEVER THE STENT REMAINED IMPLANTED. ACCESS WAS THEN GAINED FROM THE RIGHT COMMON FEMORAL SIDE, AND THEY WENT IN WITH A SNARE DEVICE TO REMOVE THE ELONGATED, IMPLANTED STENT. WHEN PULLING THE STENT OUT OF THE VESSEL AND INTO A NON-ABBOTT SHEATH FOR REMOVAL FROM THE ANATOMY, A DISSECTION OCCURRED DUE TO AN INTERACTION WITH THE OMNI ELITE STENT AND THE VESSEL WALL. ONCE THE DISSECTION WAS NOTICED, A NON-ABBOTT COVERED STENT WAS IMPLANTED TO TREAT TH

  Patient problems: Vascular Dissection

  MAUDE report 17576623 ↗
• InjuryMay 23, 2023Difficult 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 MILDLY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY. ACCESS WAS GAINED VIA THE LEFT COMMON FEMORAL ARTERY AND PRE-DILATATION WAS PERFORMED. A 7.0X59MM OMNI ELITE BALLOON-EXPANDABLE STENT (BES) WAS THEN ADVANCED, HOWEVER IT COULD NOT CROSS THE CHALLENGING ANATOMY AND HAD TO BE WITHDRAWN. DURING REMOVAL FROM THE ANATOMY, THE STENT CAME OFF THE DELIVERY BALLOON DUE TO RESISTANCE WITH THE CALCIUM OR TORTUOSITY AND WAS PARTIALLY IN THE COMMON ILIAC THAT WAS TO BE TREATED AND PARTIALLY OUTSIDE OF THE TARGET LESION. THE OMNI ELITE BALLOON WAS USED TO PARTIALLY EMBEDDED THE DISLODGED STENT IN THE COMMON ILIAC AND THE REMAINDER OF THE STENT WAS OUT OF THE TARGET LESION. A 7.0X29MM OMNILINK ELITE STENT WAS THEN DEPLOYED OVERLAPPING THE FIRST STENT TO COVER THE REMAINDER OF THE LESION AND SECURE THE DISLODGED STENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16985418 ↗
• InjuryDec 8, 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 POSTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF THE 7.0X59MM OMNILINK STENT DELIVERY SYSTEM, THE STENT GOT CAUGHT IN CALCIUM. AN ATTEMPT WAS MADE TO ADVANCE AND RETRACT THE STENT DELIVERY SYSTEM; HOWEVER, THE STENT DISLODGED DURING ADVANCEMENT. IT WAS NOTED THAT RESISTANCE WAS ALSO FELT WITH THE GUIDE CATHETER OR SHEATH, BUT IS UNKNOWN WITH WHICH ONE. A CUTDOWN WAS PERFORMED TO RETRIEVE THE DISLODGED STENT. A NEW OMNILINK STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946341 ↗
• InjurySep 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF AN 7X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) DISLODGED FROM THE BALLOON. THE STENT COULD NOT BE RETRIEVED, SO THE PATIENT WAS SENT TO SURGERY. THEIR CURRENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9039420 ↗
• InjuryDec 8, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION IN THE LEFT COMMON ILIAC ARTERY, A 8.0MMX100MMX135CM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUE TO THE LESION. THE DEVICE WAS UNLOCKED WITHOUT ISSUE. AS THE SHEATH WAS BEING RETRACTED DURING DEPLOYMENT, WITH NO RESISTANCE FELT, THE STENT APPEARED TO BE CONSTRICTED AS IT WAS BEING RELEASED AND IT WAS SLOW TO EXPAND. THE STENT WAS ULTIMATELY ABLE TO BE DEPLOYED IN THE TARGET LESION, BUT A WAIST WAS NOTED IN THE STENT. POST-DILATATION WAS PERFORMED BUT THE WAIST WAS STILL PRESENT. THUS, A 7.0MMX59MMX135CM OMNILINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO THE ABSOLUTE PRO, BUT THE OMNILINK ELITE WAS UNABLE TO CROSS THROUGH THE WAIST AREA OF THE DEPLOYED ABSOLUTE PRO TO TREAT THE WAIST. THE OMNILINK ELITE STENT WAS ALTERNATIVELY DEPLOYED, OVERLAPPING THE PROXIMAL END OF THE ABSOLUTE PRO STENT. ANOTHER SAME SIZE OMNILINK ELITE STENT WAS THEN ADVANCED AND CROSSED THE ABSOLUTE PRO WITHOUT DIFFICULTY AND WAS DEPLOYED, SUCCESSFULLY RESOLVING THE WAIST, BUT A PERFORATION RESULTED. THE PATIENT BECAME HYPOTENSIVE WHICH WAS RESOLVED WITH MEDICATION. A

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 6156500 ↗
• MalfunctionAug 8, 2016Positioning Failure; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 59 MM OMNI ELITE SELF-EXPANDING STENT SYSTEM RUPTURED DURING THE FIRST INFLATION AT 11 ATMOSPHERES. THE DEVICE WAS PREPPED PRIOR TO THE PROCEDURE PER THE INSTRUCTIONS FOR USE. THE STENT REMAINED ON THE BALLOON AND WAS REMOVED WITHOUT ISSUE. ANOTHER OMNI ELITE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5854887 ↗