MISSION 1610MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741142567), received between Jun 12, 2019 and Feb 5, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE END OF INNER NEEDLE; NEEDLE NOTCH WAS ALLEGEDLY BENT WHILE PENETRATING AND THE CUTTING DIDN'T GO ALL THE WAY. FURTHER IT WAS REPORTED THAT THE NEEDLE WAS ALLEGEDLY PULLED OUT OF THE PATIENT'S BREAST WITH FORCE. 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 18641080 ↗
• MalfunctionJan 9, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGING WAS ALLEGEDLY OPEN WITHOUT SEALING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473178 ↗
• MalfunctionFeb 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE PACKAGE WAS ALLEGEDLY MISLABELED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13520740 ↗
• InjuryJun 12, 2019Break; Break

  IT WAS REPORTED THAT DURING A TIBIA BONE BIOPSY, THE DEVICE ALLEGEDLY BROKE INSIDE THE PATIENT. THE NEEDLE WAS REMOVED FROM THE PATIENT 2 WEEKS POST PROCEDURE.

  Patient problems: Injury

  MAUDE report 8691245 ↗