MISSION 1616MSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741096976), received between Feb 22, 2022 and Feb 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MISSION INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTER CANNULA ALLEGEDLY CAN'T BE FIRED. NO COAXIAL WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451414 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MISSION INSTRUMENT. PRIOR TO THE PROCEDURE THE DEVICE ALLEGEDLY HAD LABELLING PROBLEM. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289957 ↗
• MalfunctionJun 5, 2023Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, A FOREIGN PARTICLE WAS ALLEGEDLY FOUND INSIDE THE PRIMARY CONTAINER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057606 ↗
• MalfunctionJun 5, 2023Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, BROWN STAIN WAS ALLEGEDLY FOUND IN THE NEEDLE. IT WAS FURTHER REPORTED THAT THE STERILE PACKAGING WAS NOTED TO BE DAMAGED PRIOR TO OPENING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057547 ↗
• MalfunctionApr 28, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE LABEL WAS ALLEGEDLY FOUND TO BE MISSING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14234067 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE PATIENT UPON REMOVING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576914 ↗