MISSION 1810MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741097058), received between Oct 23, 2017 and Jan 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY BY USING MISSION KIT. IT WAS REPORTED THAT DURING THE PROCEDURE THE BLUNT TROCAR ALLEGEDLY SEPARATED FROM THE NEEDLE HUB. THE COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942574 ↗
• MalfunctionSep 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE, USING THE MISSION NEEDLE KIT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COAXIAL HUB IN THE KIT WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935667 ↗
• MalfunctionDec 27, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE SEAL WAS ALLEGEDLY OPEN AT THE ONE SIDE/ BOTTOM SIDE OF NEEDLE PACK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025794 ↗
• MalfunctionNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED BIOPSY PROCEDURE, THE TROCAR NEEDLE WAS ALLEGEDLY LOOSE FROM THE PLASTIC HUB. IT WAS FURTHER REPORTED THAT THE TROCAR NEEDLE WAS ALLEGEDLY BROKEN OFF FROM PLASTIC AFTER UNPACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586500 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DETACHED FROM THE HUB RENDERING IT UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382374 ↗
• MalfunctionJun 9, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION FOR A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE OPENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097077 ↗
• MalfunctionApr 8, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BLUNT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY LONGER THAN THE ACTUAL NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638281 ↗
• MalfunctionApr 8, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE CAME WITH A BLUNT TIP STYLET THAT WAS MUCH LONGER THAN THE INTRODUCER AND NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637878 ↗
• MalfunctionMar 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FOUND FOREIGN MATERIAL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567014 ↗
• MalfunctionNov 26, 2020Device Contamination with Chemical or Other Material; Material Twisted/Bent; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY, THROUGH SOFT TISSUE, THE DEVICE NEEDLE ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT DURING EVALUATION FOREIGN MATERIAL WAS FOUND IN THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911114 ↗
• MalfunctionOct 23, 2017Bent; Defective Component

  DURING CT GUIDED LIVER BIOPSY THE BARD BIOPSY NEEDLE WAS INSIDE THE PATIENT AND BENT WHILE IN THE COAXIAL INTRODUCER. NEEDLE WAS REMOVED AND NEW BARD BIOPSY NEEDLE WAS USED WITHOUT INCIDENT. THE PROVIDER INSISTS THERE WAS NO EXCESSIVE FORCE WITH NEEDLE WAS BEING USED, AND THAT THIS WAS A DEFECTIVE PRODUCT. THE RESULT OF PREVIOUS BENT NEEDLE REQUIRED THE PATIENT'S LIVER HAD TO BE RE-BIOPSIED CREATING A HIGHER POTENTIAL RISK FOR BLEEDING POST LIVER BIOPSY PROCEDURE. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, BARD® MISSION® (PER SITE REPORTER): CR BARD REP WAS GIVEN THE BENT NEEDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6968080 ↗