MARQUEE MQ1610Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741097164), received between Nov 26, 2020 and Oct 31, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED AXILLARY LYMPH NODE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING THE MARQUEE DEVICE. DURING THE PROCEDURE, THE NEEDLE TIP WAS BENT AND ONLY A SMALL SAMPLE WAS OBTAINED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE THE NEEDLE WAS BEING EXTRACTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433571 ↗
• InjuryJul 7, 2025Break; Failure to Fire; Material Deformation; Material Twisted/Bent; Break; Failure to Fire; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MARQUEE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE STYLET WAS ALLEGEDLY BROKEN. FURTHER, THE BROKEN TIP WAS STUCK INSIDE THE PATIENT'S BREAST. IT WAS FURTHER REPORTED THAT PHYSICIAN PRESSED BUTTON A, BUT ONLY STYLET WAS FIRED AND CUTTING CANULA HAS ALLEGEDLY FAILED TO FIRE. THE PATIENT IS SCHEDULED FOR BREAST CANCER SURGERY IN THE NEAR FUTURE. AT THIS TIME, THE PATIENT DOES NOT WANT TO HAVE ADDITIONAL SURGERY FOR REMOVING THE REMAINING TIP. NO COAXIAL WAS USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22409402 ↗
• MalfunctionJun 22, 2024Break; Fracture; Failure to Prime; Failure to Obtain Sample; Break; Fracture; Failure to Prime; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE TISSUE WAS ALLEGEDLY NOT CUT. IT WAS FURTHER REPORTED THAT PRIMING WAS ALLEGEDLY STIFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591113 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507924 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507869 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507785 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507426 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507292 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507291 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IIT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507251 ↗
• MalfunctionJun 10, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496320 ↗
• MalfunctionJun 10, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496319 ↗
• MalfunctionJun 10, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496291 ↗
• MalfunctionJun 10, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD WEAK FIRING POWER AND WAS UNABLE TO GET SUFFICIENT SAMPLES. IT WAS FURTHER REPORTED THAT THE NEEDLE HAD TO BE FORCIBLY REMOVED FROM THE BREAST. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496133 ↗
• MalfunctionNov 3, 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 INNER NOTCH OF THE NEEDLE OF THE BIOPSY WAS ALLEGEDLY BENT WHEN IT ENTERED AND THE CUTTING WAS NOT DONE UNTIL THE END. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS PULLED OUT WITH FORCE UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18063205 ↗
• MalfunctionMar 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY HAD FOREIGN SUBSTANCE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13730166 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THROUGH NORMAL DENSITY TISSUE, THE PENETRATION DEPTH SWITCH/BUTTON ALLEGEDLY FELL OFF WHEN THE DEVICE WAS FIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494077 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THROUGH NORMAL DENSITY TISSUE, THE PENETRATION DEPTH SWITCH/BUTTON ALLEGEDLY FELL OFF WHEN THE DEVICE WAS FIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494074 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THROUGH NORMAL DENSITY TISSUE, THE PENETRATION DEPTH SWITCH/BUTTON ALLEGEDLY FELL OFF WHEN THE DEVICE WAS FIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494071 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED PRIOR TO A BIOPSY PROCEDURE, THE DEVICE BUTTON ALLEGEDLY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11470718 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON CORE BIOPSY INSTRUMENTS, THERE WAS ONE OCCURRENCE OF ADJACENT TISSUE INJURY DURING A LIVER BIOPSY PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10910864 ↗