MISSION 1610MSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741096969), received between Nov 1, 2020 and Feb 10, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Device Markings/Labelling Problem

  A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302072 ↗
• MalfunctionFeb 10, 2026Device Markings/Labelling Problem

  A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302070 ↗
• MalfunctionFeb 10, 2026Device Markings/Labelling Problem

  A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302067 ↗
• MalfunctionFeb 10, 2026Device Markings/Labelling Problem

  A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301976 ↗
• MalfunctionFeb 10, 2026Device Markings/Labelling Problem

  A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301971 ↗
• MalfunctionJul 15, 2025Difficult to Insert; Difficult to Insert

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR AN ULTRASOUND GUIDED AXILLARY BIOPSY THROUGH NORMAL DENSITY TISSUE USING MISSION. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCING HEMATOMA. NO COAXIAL WAS USED AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 22504092 ↗
• InjuryJun 3, 2025Difficult to Insert; Difficult to Insert

  ON (B)(6) 2025, A PATIENT UNDERWENT THE BIOPSY PROCEDURE. DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCING HEMATOMA. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 22131417 ↗
• MalfunctionMar 22, 2023Difficult 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 NEEDLE ALLEGEDLY BENT. REPORTEDLY THE NEEDLE WAS PULLED OUT BY FORCE. NO 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 16589137 ↗
• MalfunctionJul 26, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY SELF-ACTIVATED. A 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 12224604 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE MISSION BODY ALLEGEDLY BROKEN WHILE DOING THE SURGERY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019136 ↗
• MalfunctionNov 1, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE NEEDLE ALLEGEDLY STUCK IN PATIENT BREAST. A COAXIAL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10768312 ↗