Omnilink Elite 1012632-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648178566), received between Jul 17, 2019 and Nov 25, 2024 — classified as 1 injury, 2 malfunctions.

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 18, 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.

• InjuryNov 25, 2024Difficult 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 THE MILDLY TORTUOUS, HEAVILY CALCIFIED COMMON ILIAC ARTERY. WHEN ADVANCING THE 10X59MM OMNILINK ELITE STENT DELIVERY SYSTEM RESISTANCE WAS FELT WITH ANATOMY AND THE STENT DISLODGED. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS ADVANCED AND INFLATED IN THE ATTEMPT TO BRING BACK THE STENT; HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE STENT WAS HELD IN PLACE WITH DEVICE AND ANOTHER 9.0X59MM OMILINK ELITE STENT WAS ATTEMPTED TO BE ADVANCED TO TREAT THE LESION; HOWEVER, MET RESISTANCE WITH ANATOMY AND DISLODGED. THE DISLODGED STENT WAS ATTEMPTED TO BE SNARED BUT THE SNARE DEVICE BECAME STUCK WITH ANATOMY AND THE STENT. IT WAS NOTED THAT THE STENTS HAD OCCLUDED IN THE PROXIMAL EXTERNAL ILIAC ARTERY BLOCKING MOST OF THE BLOOD FLOW THROUGH THE ILIAC. THE SNARE DEVICE COULD NOT BE PULLED BACK. THE SNARE DEVICE WAS BROKEN ON PURPOSE AND THE STUCK PORTION ALONG WITH BOTH STENTS WERE CRUSHED INTO THE VESSEL WALL WITH A NON-ABBOTT STENT OVER THEM. BLOOD FLOW WAS RESTORED WHEN THE STENTS WERE CRUSHED AND CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 20774565 ↗
• MalfunctionJun 9, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED VESSEL WITHOUT TORTUOSITY IN THE LEFT ILIAC ARTERY. THE 9.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INFLATED AT 8 AND 11 ATMOSPHERES (ATMS) AND THE STENT DID NOT COME OFF THE BALLOON AND COMPLETELY FAILED TO DEPLOY. THE SDS WAS REMOVED AND A 9.0X39MM OMNI ELITE SDS WAS USED AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 14644014 ↗
• MalfunctionJul 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF A 9.00 X 59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) DISLODGED OFF THE BALLOON DURING USE; HOWEVER, REMAINED ON THE SDS. THERE WAS NO REPORTED RESISTANCE NOTED PRIOR TO THE DISLODGEMENT. THE STENT WAS REMOVED WITH THE SDS AND A NEW UNSPECIFIED DEVICE 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 Consequences Or Impact To Patient

  MAUDE report 8800608 ↗