MISSION 1816MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741097065), received between Feb 16, 2018 and Feb 10, 2026 — classified as 1 death, 6 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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. Feb 28, 2023Open, Classified

   The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.

   Z-1260-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION KIT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE HAD A PLASTIC CAP WHICH WAS ALLEGEDLY BROKE OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302203 ↗
• MalfunctionFeb 2, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MISSION KIT INSTRUMENT. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE NEEDLE WAS BROKEN IN PATIENT. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231486 ↗
• MalfunctionDec 11, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE NEEDLE SEPARATED AT THE SEAMS. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775355 ↗
• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION INSTRUMENT. DURING THE PROCEDURE, THE SCREW CAP BECAME DISCONNECTED FROM THE COAXIAL NEEDLE, AND THE BIOPSY INSTRUMENT COULD NO LONGER BE USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521850 ↗
• MalfunctionAug 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, DIFFERENT PRODUCT CODE IS ALLEGEDLY BEING LABELLED ON PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076198 ↗
• InjuryJul 10, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LIVER BIOPSY PROCEDURE, THE COAXIAL NEEDLE ALLEGEDLY BENT WHEN THE PATIENT SAT UP. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PNEUMOTHORAX WHICH WAS RESOLVED USING PNEUMOTHORAX KIT. REPORTEDLY, THE NEEDLE WAS REMOVED USING FORCEPS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 19708814 ↗
• MalfunctionJul 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE OUTER BOX OF THE DEVICE WAS ALLEGEDLY FOUND TO BE MISLABELED WITH A DIFFERENT PRODUCT CODE; HOWEVER, THE DEVICE WITHIN THE OUTER BOX WAS CORRECTLY LABELLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678321 ↗
• MalfunctionApr 9, 2024Nonstandard Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Nonstandard Device; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHIC GUIDED LUNG BIOPSY PROCEDURE, THE SHARP INNER METAL STYLET WAS ALLEGEDLY DETACHED FROM THE PLASTIC HUB AND THE NEEDLE. A 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 19069100 ↗
• MalfunctionFeb 27, 2024Device-Device Incompatibility; Component Misassembled; Device-Device Incompatibility; Component Misassembled

  IT WAS REPORTED THAT DURING A CT-GUIDED LUNG BIOPSY PROCEDURE, THE NEEDLE WAS UNABLE TO ADVANCE THROUGH THE COAXIAL. THE DEVICE AND NEEDLE WERE REMOVED AND A SECOND ATTEMPT TO OBTAIN THE BIOPSY WAS DONE WITH A NEW DEVICE OF A DIFFERENT LOT NUMBER. DURING THE PLACEMENT OF THE SECOND NEEDLE, THE PATIENT ALLEGEDLY EXPERIENCED A PNEUMOTHORAX. NO CHEST TUBE WAS PLACED AT THAT TIME THE PHYSICIAN WAS ABLE TO RESOLVE THE PNEUMOTHORAX. A COAXIAL NEEDLE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Pneumothorax

  MAUDE report 18793772 ↗
• MalfunctionFeb 20, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE THE HOLES WERE NOTED TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739079 ↗
• MalfunctionFeb 20, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE THE HOLES WERE NOTED TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739072 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Component Misassembled; Device-Device Incompatibility; Component Misassembled

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE EXTERNAL DIAMETER OF THE BIOPSY INSTRUMENT BEING LARGER THAN THE INTERNAL DIAMETER OF THE COAXIAL NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524112 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Component Misassembled; Device-Device Incompatibility; Component Misassembled

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE EXTERNAL DIAMETER OF THE BIOPSY INSTRUMENT BEING LARGER THAN THE INTERNAL DIAMETER OF THE COAXIAL NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524111 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE KIT COAXIAL WAS ALLEGEDLY NOT COMPATIBLE WITH NEEDLE. 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 18472704 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE KIT COAXIAL WAS ALLEGEDLY NOT COMPATIBLE WITH NEEDLE. 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 18472702 ↗
• MalfunctionDec 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE COAXIAL NEEDLE AVAILABLE IN THE KIT WAS ALLEGEDLY FOUND TO BE NON COMPATIBLE WITH THE BIOPSY NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253181 ↗
• MalfunctionNov 28, 2023Device-Device Incompatibility; Component Misassembled; Device-Device Incompatibility; Component Misassembled

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE COAXIAL NEEDLE AVAILABLE IN THE KIT WAS ALLEGEDLY NOT COMPATIBLE WITH THE BIOPSY NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215195 ↗
• MalfunctionNov 22, 2023Device-Device Incompatibility; Component Misassembled; Device-Device Incompatibility; Component Misassembled

  IT WAS REPORTED THAT DURING A CT GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE COAXIAL NEEDLE WAS ALLEGEDLY NOT COMPATIBLE WITH THE BIOPSY NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196146 ↗
• DeathSep 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS INITIALLY REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED KIDNEY BIOPSY PROCEDURE, THE GUIDE WAS ALLEGEDLY TOO SMALL FOR THE NEEDLE TO FIT THROUGH. IT WAS FURTHER REPORTED THAT A DIFFERENT SIZED NEEDLE WAS USED TO COMPLETE THE PROCEDURE. IT WAS LATER REPORTED THROUGH FOLLOW-UP THAT POST PROCEDURE THE PATIENT DEVELOPED A HEMATOMA AND REQUIRED A BLOOD TRANSFUSION AND REPORTEDLY EXPIRED. THE RELATIONSHIP BETWEEN THE EVENT AND THE PATIENT'S DEATH IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 17696799 ↗
• MalfunctionAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CT GUIDED LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY SUFFERED FROM PNEUMOTHORAX. COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. IT WAS FURTHER REPORTED THAT NO CHEST TUBE WAS PLACED AT THAT TIME AND PNEUMOTHORAX WAS ABLE TO BE RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pneumothorax

  MAUDE report 17660282 ↗
• InjuryAug 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED LUMBAR DISC BIOPSY PROCEDURE, THE TIP OF THE NEEDLE ALLEGEDLY BROKE OFF IN THE PATIENT. REPORTEDLY, SURGICAL PROCEDURE WAS DONE TO REMOVE THE METAL TIP. THE CURRENT STATE OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17496395 ↗
• MalfunctionJul 6, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOSPY PROCEDURE, THE COAXIAL WAS ALLEGEDLY BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265466 ↗
• InjuryJun 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY-GUIDED SACRUM LESION BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE INTO THE PATIENT. REPORTEDLY, THE NEEDLE WAS STILL INSIDE THE PATIENT AND PLANNED FOR ITS REMOVAL THROUGH ORTHOPEDIC SURGERY. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17085929 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A LIVER BIOPSY PROCEDURE THROUGH NORMAL TISSUE, THE OUTER CANNULA ALLEGEDLY BROKE IN THE PATIENT. COAXIAL 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 17008705 ↗
• MalfunctionMar 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD INCOMPATIBLE ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626699 ↗