MARQUEE MQ1816Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741097201), received between Sep 22, 2023 and Sep 23, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Remove; Material Twisted/Bent

  On (b)(6) 2026, a patient underwent an ultrasound guided lung biopsy procedure through normal tissue density using the Marquee device. During the procedure, the needle was found to be bent, specifically involving the stylet. Difficulty was also encountered while removing the product from the patient. No coaxial needle 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 50865881 ↗
• MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE 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 25064768 ↗
• MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE 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 25064767 ↗
• MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE 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 25064766 ↗
• MalfunctionJan 13, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY-GUIDED LUNG BIOPSY THROUGH SOFT DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE STYLET PART OF THE NEEDLE WAS BENT AND DIFFICULT TO REMOVE FROM THE PATIENT. A COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050674 ↗
• MalfunctionJan 7, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED LYMPH BIOPSY THROUGH NORMAL DENSITY TISSUE, USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE STYLET OF THE NEEDLE WAS ALLEGEDLY FOUND BENT AND HAVING DIFFICULTY REMOVING THE PRODUCT FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986938 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, BLUE PARTICLES WERE VISUALIZED IN THE DEVICE PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876094 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, BLUE PARTICLES WERE VISUALIZED IN THE DEVICE PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875959 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, BLUE PARTICLES WERE VISUALIZED IN THE DEVICE PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875957 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING INVESTIGATION OF THE RETURNED SEALED LOT SAMPLES FROM THE CUSTOMER, IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875744 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, BLUE PARTICLES WERE VISUALIZED IN THE DEVICE PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875716 ↗
• MalfunctionMay 29, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT THE LIVER BIOPSY PROCEDURE. DURING A CT GUIDED LIVER BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. COAXIAL NEEDLE 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 22103404 ↗
• MalfunctionMay 29, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT THE LIVER BIOPSY PROCEDURE. DURING A CT GUIDED LIVER BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. COAXIAL NEEDLE 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 22103294 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT THE LIVER BIOPSY PROCEDURE. DURING A CT GUIDED LIVER BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. COAXIAL NEEDLE 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 22076907 ↗
• MalfunctionDec 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE LABEL WAS ALLEGEDLY MISLABELED. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20950362 ↗
• MalfunctionDec 17, 2024Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping; Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE LABEL WAS ALLEGEDLY MISLABELED. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20950360 ↗
• MalfunctionSep 22, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A KIDNEY BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DID NOT FIRE INSIDE PATIENT TO OBTAIN A SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797499 ↗