MISSION 1410MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741142543), received between Apr 14, 2022 and Aug 6, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionAug 6, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE WITH THE MISSION KIT. DURING THE PROCEDURE, THE NEEDLE WAS BENT. IT WAS FURTHER REPORTED THAT IT WAS SLIGHTLY DIFFICULT TO REMOVE. 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 22724286 ↗
• MalfunctionJul 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE AFTER SAMPLING PROCESS WHILE REMOVING THE NEEDLE, A RECTANGLE-SHAPED PLASTIC ALLEGEDLY WAS FOUND IN THE NOTCH OF THE NEEDLE INTO THE SAMPLING CONTAINER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653271 ↗
• MalfunctionDec 13, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY HAD DIFFICULTY IN REMOVING FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316839 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED WITH FORCE FROM THE PATIENT'S BREAST. A COAXIAL WAS USED AND PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273373 ↗
• MalfunctionNov 6, 2023Difficult to Remove; Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent; Difficult to Remove; Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NOTCH OF NEEDLE WAS ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED OUT FROM THE BREAST BY FORCE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18071075 ↗
• MalfunctionNov 3, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NOTCH OF NEEDLE WAS ALLEGEDLY BENT WHILE PENETRATION AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED OUT FROM THE BREAST BY FORCE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065309 ↗
• MalfunctionOct 25, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NOTCH OF NEEDLE ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY REMOVED FROM THE PATIENT'S BREAST BY EXCESSIVE FORCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002158 ↗
• MalfunctionOct 12, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE INNER NEEDLE ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED OUT FROM THE BREAST BY FORCE. A COAXIAL NEEDLE 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 17925861 ↗
• MalfunctionOct 5, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED WITH FORCE FROM THE PATIENT'S BREAST. A COAXIAL WAS USED AND PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875601 ↗
• MalfunctionOct 5, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED WITH FORCE FROM THE PATIENT'S BREAST. A COAXIAL WAS USED AND PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875217 ↗
• MalfunctionOct 5, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED WITH FORCE FROM THE PATIENT'S BREAST. A COAXIAL WAS USED AND PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875138 ↗
• MalfunctionMar 25, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE INNER NEEDLE ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY REMOVED BY EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616734 ↗
• MalfunctionApr 14, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. A COAXIAL NEEDLE WAS USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110439 ↗