MARQUEE MQK1410Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741097287), received between Oct 6, 2016 and Oct 21, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 reports).

1 FDA recall record name this device's identifier.

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. Jan 14, 2021Terminated

   Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.

   Z-1289-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE BREAST BIOPSY PROCEDURE USING THE MARQUEE. DURING THE PROCEDURE, THE DEVICE COAXIAL PORTION WAS DEFECTIVE AND UNUSABLE. THE GREEN PLASTIC PORTION WAS NOT ATTACHED TO THE INNER STYLET. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345070 ↗
• MalfunctionApr 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE PENETRATION DEPTH SWITCH ALLEGEDLY FELL OFF AND HIT THE TECHNICIAN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793825 ↗
• MalfunctionApr 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE PENETRATION DEPTH SWITCH OF THE DEVICE ALLEGEDLY FELL OFF. IT WAS FURTHER REPORTED THAT THE FELL OFF SWITCH HIT THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784533 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY, THE PLASTIC HUB ON INTRODUCER ALLEGEDLY CAME OF WHILE TRYING TO REMOVE FROM CO-AXIAL. THE PROCEDURE WAS COMPLETED WITHOUT AN INTRODUCER/CO-AXIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397555 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY, THE DEVICE ALLEGEDLY SPLATTERED BLOOD BACKWARDS UP THE INTRODUCER TOWARDS THE USER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319635 ↗
• MalfunctionJan 15, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE OUTER CANNULA OF THE DEVICE WAS ALLEGEDLY NOT ATTACHED TO THE BIOPSY SYSTEM. IT WAS FURTHER REPORTED THAT THE STYLET WAS ALLEGEDLY DETACHED FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157249 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE PLASTIC SELECTOR SWITCH ALLEGEDLY DETACHED AND POPPED OFF TOWARDS PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598013 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE SELECTOR SWITCH OF THE NEEDLE ALLEGEDLY POPPED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447939 ↗
• MalfunctionOct 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE SELECTOR SWITCH ALLEGEDLY POPPED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436524 ↗
• MalfunctionFeb 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, CRUSTY WHITE STUFF WAS ALLEGEDLY FOUND ALL OVER THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786692 ↗
• MalfunctionApr 15, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, IT WAS NOTICED THAT THE PACKAGING WAS OPENED. IT WAS FURTHER REPORTED THAT THE PACKAGE WAS NOT SEALED SO THE STERILITY OF THE PACKAGE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748418 ↗
• MalfunctionApr 15, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, IT WAS NOTICED THAT THE PACKAGING WAS OPENED. IT WAS FURTHER REPORTED THAT THE PACKAGE WAS NOT SEALED SO THE STERILITY OF THE PACKAGE WAS COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748417 ↗
• MalfunctionMar 30, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY STUCK WHEN ATTEMPTING TO REMOVE FROM COAXIAL. THE PROCEDURE WAS COMPLETED WITHOUT USING THE COAXIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644548 ↗
• MalfunctionFeb 27, 2023Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DIFFICULTY REMOVING FROM BREAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442961 ↗
• MalfunctionFeb 27, 2023Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DIFFICULTY REMOVING FROM BREAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442689 ↗
• MalfunctionOct 12, 2022Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE CANNULA NEEDLE WAS ALLEGEDLY MISASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586129 ↗
• MalfunctionOct 12, 2022Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE CANNULA NEEDLE WAS ALLEGEDLY MISASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586073 ↗
• MalfunctionJun 29, 2022Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS DIFFICULT TO REMOVE FROM COAXIAL AND BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849762 ↗
• MalfunctionMar 17, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE PACKAGE ALLEGEDLY CONTAINED DIFFERENT SIZED PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802831 ↗
• MalfunctionAug 23, 2021Difficult to Remove; Firing Problem; Difficult to Remove; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. A COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353270 ↗
• MalfunctionJun 11, 2018Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample; Failure to Fire

  IT WAS REPORTED THAT DURING A BREAST BIOPSY IN DENSE TISSUE, AFTER THE FIRST SAMPLE PASS, THE CANNULA ALLEGEDLY WAS DIFFICULT TO PRIME IN ORDER TO RETRIEVE THE TISSUE SAMPLE AND THE TISSUE SAMPLE WAS OF INSUFFICIENT SIZE. ON THE SECOND SAMPLE PASS, THE DEVICE WAS FIRED USING THE SEMI-AUTOMATIC TRIGGER, BUT BOTH CANNULA AND STYLET REPORTEDLY FIRED TOGETHER. AFTER THE CANNULA WAS PRIMED AND THE SECOND TISSUE SAMPLE RETRIEVED, THE STYLET ALLEGEDLY WAS UNABLE TO PRIME. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND A COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589832 ↗
• MalfunctionOct 6, 2016Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility; Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH DENSE AND SCAR TISSUE, THE HEALTH CARE PROVIDER (HCP) NOTED THAT THEY WERE ALLEGEDLY UNABLE TO REMOVE THE DEVICE FROM THE COAXIAL AND THAT BOTH WERE STUCK IN THE TARGET TISSUE AFTER THE FIRST SAMPLE ATTEMPT. IT WAS FURTHER REPORTED THAT THE DEVICE AND COAXIAL WERE SUCCESSFULLY REMOVED BY GENTLY TWISTING OUT OF THE TARGET TISSUE. ONCE REMOVED, THE HCP ALLEGEDLY USED FORCEPS TO SEPARATE THE DEVICE AND COAXIAL TO WHAT WAS NOTED AS AN INADEQUATE TISSUE SAMPLE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THE AFFECTED DEVICE, WITHOUT THE COAXIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6003429 ↗