LAZIC 35.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250603739609), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 6, 2023Open, Classified

   Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

   Z-1278-2024 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionApr 9, 2024Mechanical Problem; Mechanical Problem

  THE INCIDENT OCCURED IN ECUADOR. OUR DISTRIBUTOR IN ECUADOR HAS RECEIVED THE FOLLOWING INFORMATION FROM HIS CUSTOMER: THE APPLIER FAILED DURING SURGERY. THE APPLIER DID NOT RELEASE THE CLIP. THE APPLIER REMAINED ATTACHED TO THE CLIP. THE AFFECTED APPLIER AND ALL SIMILAR APPLIERS WITH THE ARTICLE NUMBERS 35.410, 35.411 AND 35.412 ARE BEING REMOVED FROM THE MARKET. THESE ARE ALL APPLIERS WITH A RIGID JAW. IT IS PLANNED TO REDESIGN THE JAW PART OF THE APPLIER TO PREVENT THE DEFECT FROM RECURRING AS FAR AS POSSIBLE. TO THIS END, PROTOTYPES WERE PRODUCED AND GIVEN TO VARIOUS DOCTORS IN ORDER TO OBTAIN FEEDBACK ON THE REDESIGN OF THE JAW PARTS. THE PATIENT WAS NOT INJURED. HOWEVER, THE INCIDENT COULD HAVE LED TO A DETERIORATION OF THE HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069584 ↗