Omnilink Elite 1012622-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648179181), received between Oct 12, 2017 and Jan 24, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED AND TORTUOUS LEFT INTERNAL ILIAC ARTERY. THE 6.0 X 19 MM OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY DIFFICULTY WAS NOTED ADVANCING. THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM BALLOON, BUT REMAINED ON THE GUIDE WIRE. THE DEVICE WAS PULLED BACK INTO THE SHEATH, WITH THE DISLODGED STENT REMAINING ON THE GUIDE WIRE. THE OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM AND DISLODGED STENT WERE ABLE TO REMOVED WITHOUT DIFFICULTY OR ADDITIONAL INTERVENTION. THE PROCEDURE CONTINUED WITH USE OF A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339170 ↗
• InjurySep 17, 2018Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT A LESION IN THE SUPERIOR MESENTERIC ARTERY. A 6.0MMX19MMX80CM OMNI ELITE STENT WAS IMPLANTED WITHOUT ISSUE. THE PATIENT WAS STARTED ON PLAVIX ON (B)(6) 2018. TWO OR THREE WEEKS AFTER THE PROCEDURE (DATE UNKNOWN), THE PATIENT DEVELOPED A RASH, ITCHING AND HIVES THROUGHOUT THE BODY. THE PATIENT SAW HER PRIMARY DOCTOR AND THE PATIENT WAS GIVEN PREDNISONE AND HYDROXYZINE. THE PHYSICIAN INFORMED THE PATIENT THE REACTION SHE IS HAVING DOES NOT APPEAR TO BE RELATED TO AN ANTIBIOTIC SHE IS TAKING FOR DENTAL TREATMENT PERFORMED AFTER THE STENT IMPLANT PROCEDURE. THE PATIENT WAS TAKING THE ANTIBIOTIC FROM (B)(6) TO (B)(6). THE PATIENT WILL SEE AN ALLERGIST AND DERMATOLOGIST THIS WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 7882803 ↗
• MalfunctionOct 23, 2017Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT PRIOR TO INSERTION INTO THE SHEATH, THE STENT STRUT ON THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS NOTED TO BE FLARED. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DISLODGED AND LOCATED ON THE DISTAL SHAFT. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THE STENT DISLODGED WHEN BEING INTRODUCED INTO THE HEMOSTATIC VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6968557 ↗
• MalfunctionOct 12, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ANGULATED LESION IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE 6X19 OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER COULD NOT CROSS DUE TO THE ACUTE ANGULATION OF THE SMA. WHEN PULLING BACK ON THE SDS, THE STENT DISLODGED FROM THE BALLOON. THE SHEATH WAS ADVANCED OVER THE DISLODGED STENT AND THE SHEATH WAS REMOVED WITH THE STENT INSIDE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946517 ↗