LiNA Gold Loop™ EL-200-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708265001354), received between Aug 23, 2018 and Aug 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2018Break

  DR. (B)(6) WAS USING THE LINA GOLD LOOP AND THE PATIENTS RIGHT EXTERNAL ILIAC ARTERY WAS NICKED. VIA 2ND HAND INFO, A NURSE SAID THAT THE LOOP BROKE, BUT IT'S UNCLEAR WHAT SPECIFICALLY WAS MEANT BY THE TERM "BROKE". THE NURSE DID NOT KNOW THE GENERATOR TYPE, NOR THE GENERATOR SETTINGS. WHEN ASKED IF THE UTERINE MANIPULATOR WAS POSSIBLY LEFT IN PLACE, THE NURSE DID NOT KNOW, BUT SAID THE SURGEON HAD EXPERIENCE USING THE LOOP PREVIOUSLY.

  Patient problems: Perforation

  MAUDE report 7808256 ↗