N/A (REF B12LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825020897), received between Oct 24, 2024 and Apr 21, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. Aug 19, 2026Open, Classified

   Reusable access port system may crack or seperate during use.

   Z-3185-2026 · Root cause: Device Design · FDA record ↗

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.

• InjuryApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN PERFORMING A THORACOSCOPIC LUNG DECORT/VATS AND REMOVING THE SIZE 12 TROCAR, THE TROCAR SLEEVE BROKE INTO PIECES. AS REPORTED, SOME PIECES WENT INSIDE OF THE PATIENT. ALL PIECES WERE RETRIEVED EXCEPT FOR PIECES THAT WERE TOO SMALL TO SEE. THERE WERE NO SAMPLES AVAILABLE FOR INVESTIGATION. AN X-RAY WAS NOT USED TO LOCATE THE PIECES AND A LARGER INCISION WAS NOT MADE TO RETRIEVE THE BROKEN PIECES. THERE WAS NO OTHER PATIENT INJURY REPORTED AND THERE WAS NO MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21874663 ↗
• InjuryOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TROCAR HAD A BROKEN TIP. AS REPORTED, THE MISSING PART COULD NOT BE FOUND ON X-RAY AND THE SURGEON DID NOT NOTICE IF THE BROKEN TIP WAS ALREADY THERE BEFORE THE INTRODUCTION. NO OTHER INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20529084 ↗