MARQUEE MQ1820Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741097218), received between May 8, 2019 and Feb 12, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDANCE LUNG BIOPSY PROCEDURE THROUGH SOFT DENSITY TISSUE USING MARQUEE KIT INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE WAS BENT, AND NEEDLE WAS VERY DIFFICULT TO REMOVE FROM THE PATIENT. COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319981 ↗
• MalfunctionOct 10, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL AND HARD DENSITY TISSUE, USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND DIFFICULT TO REMOVE FROM THE PATIENT. NO 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 23265120 ↗
• MalfunctionOct 10, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL AND HARD DENSITY TISSUE, USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND DIFFICULT TO REMOVE FROM THE PATIENT. NO 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 23265116 ↗
• MalfunctionMay 14, 2025Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY CAUSING THE PART TO FALL OFF AND THE INTRODUCER NEEDLE FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016875 ↗
• MalfunctionMay 7, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY THROUGH NORMAL DENSITY TISSUE, DURING THE PROCEDURE THE STYLET OF THE NEEDLE WAS BENT. NO COAXIAL NEEDLE WAS USED. FURTHER, IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977206 ↗
• MalfunctionMay 7, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY THROUGH NORMAL DENSITY TISSUE, DURING THE PROCEDURE THE STYLET OF THE NEEDLE WAS BENT. NO COAXIAL NEEDLE WAS USED. FURTHER, IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977196 ↗
• MalfunctionMay 7, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY THROUGH NORMAL DENSITY TISSUE, DURING THE PROCEDURE THE STYLET OF THE NEEDLE WAS BENT. NO COAXIAL NEEDLE WAS USED. FURTHER, IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977176 ↗
• MalfunctionMay 6, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MARQUEE. DURING THE PROCEDURE, THE STYLET OF THE DEVICE ALLEGEDLY BENT. REPORTEDLY THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966803 ↗
• MalfunctionMay 6, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MARQUEE. DURING THE PROCEDURE, THE STYLET OF THE DEVICE ALLEGEDLY BENT. REPORTEDLY THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966800 ↗
• MalfunctionMay 6, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MARQUEE. DURING THE PROCEDURE, THE STYLET OF THE DEVICE ALLEGEDLY BENT. REPORTEDLY THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966798 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Failure to Fire; Noise, Audible; Fluid/Blood Leak; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT POST A PROSTATE BIOPSY PROCEDURE, THE BLOOD WAS ALLEGEDLY SPLATTERED BACK IN THE DOCTOR SHIRT. IT WAS FURTHER REPORTED THAT THE SPRING MECHANISM FELT TIGHTER, AND THE SOUND WAS LOUDER THAN USUAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21804109 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Failure to Fire; Noise, Audible; Fluid/Blood Leak; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT POST PROSTATE BIOPSY PROCEDURE, THE BLOOD WAS ALLEGEDLY SPLATTERED BACK IN THE DOCTOR SHIRT. IT WAS FURTHER REPORTED THAT THE SPRING MECHANISM FELT TIGHTER, AND THE SOUND WAS LOUDER THAN USUAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21804103 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Failure to Fire; Noise, Audible; Fluid/Blood Leak; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT POST A PROSTATE BIOPSY PROCEDURE, THE BLOOD WAS ALLEGEDLY SPLATTERED BACK IN THE DOCTOR SHIRT. IT WAS FURTHER REPORTED THAT THE SPRING MECHANISM FELT TIGHTER, AND THE SOUND WAS LOUDER THAN USUAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21803317 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE WHEN FIRING, THE DEVICE ALLEGEDLY MIGRATED THROUGH THE LIVER AND INTO DIAPHRAGM. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FIRED BEYOND THE INSERTION LINE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21371239 ↗
• MalfunctionJun 17, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE, THE CANNULA OF THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THERE WAS AN ALLEGED DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. 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 19545281 ↗
• MalfunctionFeb 9, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE LABEL WAS FOUND MISLABELED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16333710 ↗
• MalfunctionMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROSTATE BIOPSY, THE PATIENT DEVELOPED A HEMATOMA AFTER THE PROCEDURE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hematoma; No Consequences Or Impact To Patient

  MAUDE report 8592152 ↗
• MalfunctionMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROSTATE BIOPSY, THE PATIENT DEVELOPED A HEMATOMA AFTER THE PROCEDURE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 8592054 ↗
• MalfunctionMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROSTATE BIOPSY, THE PATIENT DEVELOPED A HEMATOMA AFTER THE PROCEDURE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hematoma; No Consequences Or Impact To Patient

  MAUDE report 8592048 ↗