MISSION 2016MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741097096), received between Mar 14, 2017 and Jul 3, 2026 — classified as 12 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Contamination; Device Damaged Prior to Receipt by User

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION DEVICE. PRIOR TO THE PROCEDURE, THE DEVICE SOAKED IN SOME SORT OF LIQUID. FURTHER IT WAS REPORTED THAT NO LONGER STERILE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701923 ↗
• MalfunctionMay 5, 2026

  PATIENT CAME IN FOR AN OUTPATIENT CT GUIDED LUNG BIOPSY. DR. [REDACTED] USED BARD BIOPSY NEEDLE AS HE NORMALLY DOES. HE WAS ABLE TO GET SOME SAMPLES AT FIRST BUT ON HIS NEXT ATTEMPT HE SAID THE NEEDLE WAS NOT GOING IN. WE STOPPED GETTING SAMPLES, DR [REDACTED] PULLED THE NEEDLE OUT, ANYWAY WE HAD ENOUGH SAMPLES ACCORDING TO THE PATHOLOGIST. POST PROCEDURE SCAN WAS DONE, AND IT SHOWED SMALL PNEUMOTHORAX AND A NEEDLE SEGMENT WAS NOTED ON WHERE THE BIOPSY SITE WAS. INCIDENT EXPLAINED TO PATIENT AND WIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081076 ↗
• MalfunctionFeb 2, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231321 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING THROUGH THE MISSION DEVICE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PLASTIC TOP OF THE DEVICE HAD ALLEGEDLY COME OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955543 ↗
• InjuryAug 20, 2025Failure to Prime; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent; Failure to Prime; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A LUNG BIOPSY PROCEDURE USING MISSION KIT INSTRUMENT. DURING THE PROCEDURE THE BIOPSY NEEDLE COULDN'T BE COCKED AND THE NEEDLE BROKE AND WAS STUCK INSIDE PATIENT¿S BODY. AFTER ACTIVATING THE BIOPSY NEEDLE, THE BIOPSY NEEDLE COVER WAS DETACHED. ADDITIONALLY, THE SAMPLE WAS TRAPPED INSIDE THE NEEDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22847107 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802572 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802566 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801903 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801902 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801901 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE USING THE MISSION. DURING THE PROCEDURE, THE DEVICE MALFUNCTIONED AS THE INNER STYLET HUB WAS DISCONNECTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801900 ↗
• InjuryApr 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A COMPUTER-TOMOGRAPHY GUIDED BIOPSY PROCEDURE VIA VERTICAL APPROACH, THE NEEDLE ALLEGEDLY BROKE AND WAS LEFT BEHIND INSIDE THE PATIENT. A COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21812151 ↗
• MalfunctionMar 14, 2025

  THE PATIENT WAS IN IR (INTERVENTIONAL RADIOLOGY) FOR A COMPUTER-TOMOGRAPHY (CT) GUIDED BIOPSY. MEDICAL DOCTOR USED CT IMAGING TO LOCATE THE TARGET, L5-S1 DISC. A 20G 16 CM BARD MISSION NEEDLE WAS CHOSEN. THE DISC SPACE WAS REACHED USING CT FLUOROSCOPY. DURING SAMPLE COLLECTION, MD ASKED FOR A SECOND BARD MISSION NEEDLE. AFTER A FEW SPECIMENS WERE COLLECTED MD REMOVED THE NEEDLE AND STYLET. HE STATED THAT A PIECE OF THE NEEDLE BROKE OFF AND LEFT BEHIND. IT WAS VISIBLE ON CT FLUOROSCOPY IMAGING.

  Patient problems: Foreign Body In Patient

  MAUDE report 21605296 ↗
• MalfunctionFeb 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY THROUGH NORMAL DENSITY TISSUE, THE COAXIAL NEEDLE WAS ALLEGEDLY BROKE AT THE HUB DURING THE SECOND SAMPLE ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357170 ↗
• MalfunctionDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE INTRODUCER NEEDLE PLASTIC TIP ALLEGEDLY CAME OFF THE NEEDLE. IT WAS FURTHER REPORTED THAT THE PLACEMENT NEEDLE WAS TAKEN OUT AND THE INTRODUCER NEEDLE REMAINED IN THE PATIENT. REPORTEDLY, THERE WAS NO NEEDLE INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911265 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A SAMPLE EVALUATION, THE COAXIAL NEEDLE ALLEGEDLY HAD A BREAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840386 ↗
• MalfunctionNov 15, 2024

  PATIENT PRONE, AND LOCALIZER NEEDLE PLACED FOR RIGHT LUNG BIOPSY. DURING SECOND PASS OF BIOPSY, THE INTRODUCER NEEDLE PLASTIC TIP CAME OFF THE NEEDLE. LEAVING THE NEEDLE BEHIND IN THE PATIENT, AND THE PLASTIC TIP IN THE RADIOLOGISTS HAND. BIOPSY WAS TERMINATED AT THIS POINT. PLACEMENT NEEDLE WAS REMOVED, INTRODUCER NEEDLE STAYED IN PATIENT. WAS PULLED OUT SEPERATE, AND ADDITIONAL IMAGES SHOWED NO NEEDLE INSIDE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20693746 ↗
• InjuryJul 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A COMPUTERIZED TOMOGRAPHY GUIDED LUNG BIOPSY PROCEDURE, NEEDLE WAS ALLEGEDLY BROKE OFF AND REMAINED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT SUFFERED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED AND STAYED OVERNIGHT. REPORTEDLY, THE PATIENT WAS DISCHARGED AFTER PNEUMOTHORAX RESOLUTION AND CHEST TUBE REMOVAL. FURTHERMORE, THE BROKEN NEEDLE WAS REMOVED FROM THE PATIENT BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 17297176 ↗
• InjuryApr 25, 2023Break; Break

  IT WAS REPORTED THAT DURING LUNG BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY FRACTURED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT WHILE ATTEMPTING TO REMOVE THE NEEDLE, THE DEVICE WAS FRACTURED FURTHER RESULTING IN A FOUR CENTIMETRE FRAGMENT PROTRUDING INTO THE INTERCOSTAL MUSCLES, TRAVERSING THE PLEURAL SPACE AND THEN ENTERING THE LOWER LOBE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16804649 ↗
• InjuryApr 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN INTO TWO PIECES IN THE PATIENT'S LUMBAR DISC. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO BE TAKEN FROM CT TO FLURO TO HAVE THIS REMOVED WITH THE HELP OF A TRAUMA SURGEON TO REMOVE THE PIECES. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 16768310 ↗
• MalfunctionApr 10, 2023Difficult to Insert; Difficult to Remove; Failure to Obtain Sample; Difficult to Insert; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE AND ALSO DIFFICULT TO REMOVE FROM PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706911 ↗
• InjuryMar 28, 2023Entrapment of Device; Fracture; Material Twisted/Bent

  DURING AN IR PROCEDURE FOR BIOPSY OF A LUNG LESION, THE PATIENT COUGHED, AND THIS RESULTED IN THE BENDING OF THE 19 G OUTER CANNULA AT AN ACUTE ANGLE. GENTLE TRACTION WAS APPLIED RESULTING IN THE FRACTURE OF THE NEEDLE. WHILE ATTEMPTING TO REMOVE THE NEEDLE, THE DEVICE FRACTURED FURTHER RESULTING IN A 4CM FRAGMENT PROTRUDING INTO THE INTERCOSTAL MUSCLES, TRAVERSING THE PLEURAL SPACE AND THEN ENTERING THE LOWER LOBE.

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 16627056 ↗
• InjuryFeb 13, 2023Break; Break

  IT WAS REPORTED THAT DURING COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY PROCEDURE, THE OUTER DISTAL PORTION OF THE COAXIAL CANNULA ALLEGEDLY BROKE OFF IN THE PATIENT. IT WAS FURTHER REPORTED THAT A SURGICAL CUTDOWN PROCEDURE WAS PERFORMED TO REMOVE THE BROKE PART OF THE COAXIAL CANNULA. REPORTEDLY THE BROKEN PIECE WAS REMOVED. THE CURRENT PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 16361603 ↗
• MalfunctionSep 6, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY RECEIVED AS UNSEALED PACK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359450 ↗
• MalfunctionAug 17, 2022Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238614 ↗