LiNA Bipolar Loop™ BL-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708265004621), received between Sep 3, 2019 and Oct 21, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 21, 2024Fracture; Fracture

  INFORMATION WHICH WAS PROVIDED TO LINA MEDICAL BY US DISTRIBUTOR: "PRODUCT BROKE INSIDE OF PT, PIECES RECOVERED BY SURGEON". "ALL VISIBLE FRAGMENTS WERE REMOVED, CAVITY IRRIGATED AND ASPIRATED".

  Patient problems: Insufficient Information

  MAUDE report 20492082 ↗
• MalfunctionOct 1, 2019Break; Failure to Cut

  DESCRIPTION PROVIDED BY INITIAL REPORTER: "INITIAL ATTEMPT AT AMPUTATING THE UTERINE BODY FROM THE CERVIX WITH A LINA LOOP RESULTED IN THE LINA LOOP WIRE BREAKING AND NOT CUTTING. ALL PARTS OF THE LINA LOOP WERE REMOVED FROM THE BODY AND NO INJURY RESULTED" DATE OF EVENT: (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138244 ↗
• MalfunctionSep 3, 2019Break; Failure to Cut

  INITIAL ATTEMPT AT AMPUTATING THE UTERINE BODY FROM THE CERVIX WITH A LINA LOOP RESULTED IN THE LINA LOOP WIRE BREAKING AND NOT CUTTING. ALL PARTS OF THE LINA LOOP WERE REMOVED FROM THE BODY AND NO INJURY RESULTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955185 ↗