NA 324.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982190932), received between Jul 17, 2019 and Apr 17, 2023 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Break; Break

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT UPON RECEIPT OF THE KIT ON FEBRUARY 8, 2023, WHEN CONTROLLING THE ANCILLARY LISS, THE CUSTOMER NOTICED THAT THE PIECE 324.019 WAS BROKEN. ALSO, THE COVER DID NOT HOLD CLOSED, SO THE SCREWS WERE OUT OF THE RACK. THIS REPORT IS FOR A STOPPER FOR LISS INSERTION GUIDES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755653 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE STOPPER FOR LISS INSERTION GUIDES WAS DISCOVERED BROKEN. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8798055 ↗