MISSION 1410MSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741096945), received between Jun 28, 2018 and Feb 9, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING THE MISSION. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE DEVICE BARCODE NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289965 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING THE MISSION. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE DEVICE BARCODE NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289964 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING THE MISSION. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE DEVICE BARCODE NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289962 ↗
• InjuryMay 5, 2025Failure to Obtain Sample; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LIVER BIOPSY THROUGH HARD DENSITY TISSUE USING MISSION DISPOSABLE BIOPSY NEEDLE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. IT WAS FURTHER REPORTED THAT POST PUNCTURE, THE PATIENT ALLEGEDLY EXPERIENCED HEMORRHAGE AND SUBSEQUENT HEMORRHAGIC SHOCK AND HEMOPERITONEUM REQUIRING SURGICAL INTERVENTION WITH EXPLORATORY LAPAROTOMY TO CONTROL BLEEDING. NO COAXIAL WAS USED. CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21958545 ↗
• MalfunctionJan 25, 2024Difficult 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 THROUGH HARD DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE TISSUE COLLECTION FAILED, AND TISSUE TEAR WAS ALLEGEDLY FELT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578135 ↗
• MalfunctionJan 25, 2024Difficult 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 THROUGH HARD DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE TISSUE COLLECTION FAILED, AND TISSUE TEAR WAS ALLEGEDLY FELT. REPORTEDLY, THE NEEDLE GUARD PROTECTOR WAS NOT IN PLACE UPON OPENING THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578089 ↗
• MalfunctionJan 25, 2024Difficult 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 THROUGH HARD DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE TISSUE COLLECTION FAILED, AND TISSUE TEAR WAS ALLEGEDLY FELT. REPORTEDLY, THE NEEDLE GUARD PROTECTOR WAS NOT IN PLACE UPON OPENING THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578047 ↗
• MalfunctionJan 25, 2024Difficult 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 THROUGH HARD DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE TISSUE COLLECTION FAILED, AND TISSUE TEAR WAS ALLEGEDLY FELT. REPORTEDLY, THE NEEDLE GUARD PROTECTOR WAS NOT IN PLACE UPON OPENING THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577996 ↗
• MalfunctionDec 14, 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 WAS ALLEGEDLY FOUND TO BE BENT WHICH LED TO TISSUE COLLECTION FAILURE AND TISSUE TEAR WAS ALLEGEDLY FELT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325253 ↗
• MalfunctionOct 5, 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 WAS ALLEGEDLY FOUND TO BE BENT UNDER ULTRASOUND, TISSUE COLLECTION FAILED AND TISSUE TEAR WAS ALLEGEDLY FELT. IT WAS FURTHER REPORTED THAT THE SAMPLE WAS ALLEGEDLY FORCIBLY REMOVED DUE TO TISSUE COLLECTION FAILURE. 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 17875976 ↗
• MalfunctionOct 5, 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 WAS ALLEGEDLY FOUND TO BE BENT UNDER ULTRASOUND, TISSUE COLLECTION FAILED AND TISSUE TEAR WAS ALLEGEDLY FELT. IT WAS FURTHER REPORTED THAT THE SAMPLE WAS ALLEGEDLY FORCIBLY REMOVED DUE TO TISSUE COLLECTION FAILURE. 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 17875864 ↗
• MalfunctionOct 5, 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 WAS ALLEGEDLY FOUND TO BE BENT UNDER ULTRASOUND, TISSUE COLLECTION FAILED AND TISSUE TEAR WAS ALLEGEDLY FELT. IT WAS FURTHER REPORTED THAT THE SAMPLE WAS ALLEGEDLY FORCIBLY REMOVED DUE TO TISSUE COLLECTION FAILURE. 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 17875113 ↗
• MalfunctionSep 7, 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 TISSUE, THE NEEDLE ALLEGEDLY BENT WHILE PENETRATING DURING A BREAST BIOPSY AND THE CUTTING DIDN'T GO ALL THE WAY. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE BREAST. 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 17698103 ↗
• MalfunctionMay 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, BLUE FOREIGN MATTER IN THE PLASTIC BLISTER WAS ALLEGEDLY FOUND. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858637 ↗
• MalfunctionJun 28, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY, THE NEEDLE ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE PATIENT AFTER FIRING ON THE SECOND SAMPLE PASS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648805 ↗