MISSION 2010MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741097089), received between Apr 10, 2020 and Sep 29, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Apr 11, 2023Open, Classified

   Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.

   Z-1564-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929320 ↗
• MalfunctionDec 18, 2025Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ON (B)(6) 2025, A 66-YEAR-OLD FEMALE PATIENT UNDERWENT AN ULTRASOUND GUIDED LYMPH BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MISSION DEVICE. POST PROCEDURE, IT WAS REPORTED THAT THE NEEDLE WAS ALLEGEDLY BROKEN. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835891 ↗
• MalfunctionDec 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A 66-YEAR-OLD FEMALE PATIENT UNDERWENT AN ULTRASOUND GUIDED LYMPH BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MISSION DEVICE. POST PROCEDURE, IT WAS REPORTED THAT THE NEEDLE WAS ALLEGEDLY BROKEN. NO COAXIAL NEEDLE WAS USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835890 ↗
• InjuryMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A LUNG BIOPSY PROCEDURE USING MISSION NEEDLE. DURING A COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY, THE NEEDLE DETACHED FROM THE TIP AND THE DETACHED NEEDLE IS INSIDE THE PATIENT'S RIB CAGE. COAXIAL WAS USED. THE INCIDENT OCCURRED DURING THE PROCEEDINGS, PRECISELY TOWARDS THE END OF THE PROCEEDINGS. THE REMOVAL OF THE STAKE IS THE LAST STEP IN THE PROCEDURE BEFORE THE SKIN DRESSING IS APPLIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22095413 ↗
• MalfunctionSep 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN WHILE FIRING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164769 ↗
• InjuryAug 5, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE, THE COAXIAL NEEDLE ALLEGEDLY BROKE OFF INTO THE PATIENT. IT WAS FURTHER REPORTED THAT A SMALL CUT DOWN WAS DONE TO GET IT OUT BUT IT WAS UNABLE TO BE REMOVED. REPORTEDLY, THE PATIENT WAS MOVED TO INTERVENTIONAL RADIOLOGY TO UTILIZE X-RAY TO REMOVE IT. THE HUB OF THE NEEDLE WAS EXTREMELY DIFFICULT TO EXTRACT BUT IT WAS COMPLETED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19905789 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DID NOT EXTEND. IT WAS FURTHER REPORTED THAT THE DEVICE AND INTRODUCER ALLEGEDLY HAD COMPATIBILITY ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885167 ↗
• MalfunctionJan 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE LABEL ALLEGEDLY DID NOT MATCH THE PRODUCT THAT WAS INSIDE THE BOX. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501132 ↗
• MalfunctionFeb 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359851 ↗
• InjuryJun 2, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN INSIDE THE PATIENT. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE NEEDLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14571349 ↗
• MalfunctionMar 23, 2022Device Markings/Labelling Problem; Device-Device Incompatibility; Device Markings/Labelling Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE WRONG SIZE COAXIAL NEEDLE WAS ALLEGEDLY GIVEN IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13868668 ↗
• InjuryMay 28, 2020Break; Break

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED VERTEBRAL (T10) BIOPSY, THE DEVICE ALLEGEDLY FRACTURED AT THE LEVEL OF HUB INSIDE THE PATIENT. PATIENT WAS BROUGHT BACK TO IR THE DAY AFTER TO RETRIEVE THE NEEDLE UNDER FLUOROSCOPY. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10099407 ↗
• MalfunctionApr 10, 2020Break; Break

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2010MSK BIOPSY INSTRUMENT EXPERIENCED A NEEDLE BREAK. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE BOTH MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, GENDER, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950505 ↗