Omnilink Elite 1012630-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648178474), received between Apr 15, 2019 and Sep 15, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2022Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ILIAC ARTERY WITH CALCIFICATION AND 70% STENOSIS. INTRAVASCULAR ULTRASOUND WAS PERFORMED AND A 6FR 10 CM SHEATH WAS USED. THE 7.0X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO NOMINAL PRESSURE AND IT WAS THOUGHT TO HAVE DEPLOYED THE STENT; HOWEVER, SOMETHING WAS NOTICED FLOATING IN THE AORTA AND IT WAS DETERMINED TO BE THE STENT. THE STENT DISLODGED [MIGRATED] INTO THE AORTA ONCE DEFLATION WAS COMPLETED. THERE WERE NO ISSUES NOTED DURING INFLATION OR DEFLATION AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. A SNARE WAS USED TO RETRIEVE THE STENT FROM THE AORTA THRU THE OTHER GROIN. ANOTHER OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS A DELAY IN THE PROCEDURE, BUT THERE WAS NO IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432671 ↗
• InjuryAug 22, 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 PERFORMED EMERGENTLY, TREATING RIGHT LEG PAIN. THE TARGET LESION WAS IN THE RIGHT ILIAC ARTERY, VIA LEFT COMMON FEMORAL ACCESS. THE OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO TRAVERSE THE BIFURCATION, DUE TO SEVERE CALCIFICATION. THE DECISION WAS MADE TO TRY ACCESS VIA THE RIGHT COMMON FEMORAL ARTERY; HOWEVER, THE DEVICE WAS STILL UNABLE TO CROSS. ACCESS THEN ATTEMPTED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS BALLOONED WITH AN UNSPECIFIED DILATATION CATHETER AND THE OMNILINK WAS ADVANCED; HOWEVER, THE DEVICE WAS STILL UNABLE TO CROSS THE TARGET LESION. ONLY THE FRONT PORTION OF THE OMNILINK WAS ABLE TO CROSS. THE DECISION MADE TO ADVANCE A NON-ABBOTT SHEATH; HOWEVER, THE SHEATH BECAME CAUGHT ON THE PROXIMAL EDGE OF THE STENT. THE PHYSICIAN TRIED TO PULL THE STENT DELIVERY SYSTEM INTO THE SHEATH; HOWEVER, THE STENT DISLODGED AND EMBOLIZED TO THE RIGHT COMMON FEMORAL ARTERY. AN ATTEMPT WAS MADE TO SNARE THE DISLODGED STENT; BUT THIS WAS NOT POSSIBLE. THE STENT REMAINED IN THE COMMON FEMORAL ARTERY AND A CUT-DOWN PROCEDURE WAS PERFORMED. THE STENT WAS ABLE TO BE REMOVED. A PATCH WAS PLACED ON THE RIGHT COMMON F

  Patient problems: Embolism/Embolus

  MAUDE report 15272334 ↗
• InjuryApr 15, 2019Difficult 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 PERFORMED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY. THE VESSEL WAS NOT PRE-DILATED. A 7.0X39MM OMNILINK ELITE OTW STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE TARGET LESION. THE SDS THEN BECAME STUCK WITH THE ANATOMY AND THE STENT DISLODGED FROM THE BALLOON IN THE COMMON ILIAC ARTERY. THE SDS WAS REMOVED, AND ANOTHER OMNILINK SDS WAS THEN ADVANCED AND THE STENT WAS DEPLOYED TO CRUSH THE DISLODGED OMNILINK STENT INTO THE VESSEL WALL, WITHIN THE TARGET LESION, AND THE PROCEDURE CONCLUDED. THERE WAS NO ADVERSE PATIENT SEQUELA, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8514246 ↗