MISSION 1816MSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741096990), received between Oct 21, 2019 and Dec 26, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MISSION KIT INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE WAS BENT AND WAS DIFFICULT TO REMOVE THE NEEDLE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894778 ↗
• MalfunctionApr 9, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH NORMAL, SOFT AND HARD DENSITY TISSUE, THE NEEDLE OF THE DEVICE ALLEGEDLY BENT. IT WAS FURTHER REPORTED THE NEEDLE WAS DIFFICULT TO REMOVE FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21803680 ↗
• MalfunctionNov 4, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LYMPH BIOPSY THROUGH NORMAL DENSITY TISSUE, THE CANNULA OF THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597736 ↗
• MalfunctionFeb 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, A HAIR WAS ALLEGEDLY FOUND IN THE STERILE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719133 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON CORE BIOPSY INSTRUMENTS, THERE WAS ONE OCCURRENCE OF BLEEDING DURING KIDNEY BIOPSY PROCEDURE WHICH REQUIRED INTERVENTION. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11277369 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON LUNG BIOPSIES, A CHEST TUBE PLACEMENT REQUIRED PROLONGED ADMISSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10121439 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON LIVER BIOPSIES, THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED TRANSFUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Intermenstrual Bleeding

  MAUDE report 10115529 ↗
• MalfunctionOct 21, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1816MS BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A DEVICE MARKINGS ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9214202 ↗