MISSION 1616MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741142574), received between Jun 3, 2021 and Jul 8, 2026 — classified as 2 injuries.

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. Nov 8, 2023Open, Classified

   The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.

   Z-0643-2024 · Root cause: Process control · 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.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  A patient underwent a liver biopsy procedure using a Mission instrument. Following the procedure, the patient experienced severe bleeding and significant blood loss, estimated at approximately six liters. It was further reported that the patient experienced a life threatening hemorrhagic event and required emergency intervention, including surgery and embolization, to control the bleeding. The current status of the patient is unknown.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25743621 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY HAD PNEUMOTHORAX. PATIENT REPORTED STABLE.

  Patient problems: Pneumothorax

  MAUDE report 11928657 ↗