MARQUEE MQ1825Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741097225), received between Oct 13, 2021 and Sep 25, 2026 — classified as 13 malfunctions.

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

• MalfunctionSep 25, 2026Difficult to Remove

  On (b)(6) 2026, a male patient underwent an ultrasound guided prostate biopsy procedure using a Marquee biopsy instrument via a transrectal approach. During the procedure, the biopsy cannula bent after four tissue samples were obtained. A second instrument with the same reference number and lot number was subsequently used; however, the same issue recurred, with the biopsy cannula bending after four tissue samples were collected. It was further reported that difficulty was encountered while withdrawing the bent cannula from the patient. The procedure was ultimately completed using a third device. The patient experienced discomfort and pain, for which 1percent lidocaine was administered. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893720 ↗
• MalfunctionSep 25, 2026Difficult to Remove

  On (b)(6)2026, a male patient underwent an ultrasound guided prostate biopsy procedure using a Marquee biopsy instrument via a transrectal approach. During the procedure, the biopsy cannula bent after four tissue samples were obtained. A second instrument with the same reference number and lot number was subsequently used; however, the same issue recurred, with the biopsy cannula bending after four tissue samples were collected. It was further reported that difficulty was encountered while withdrawing the bent cannula from the patient. The procedure was ultimately completed using a third device. The patient experienced discomfort and pain, for which 1percent lidocaine was administered. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893713 ↗
• MalfunctionMay 5, 2026Break

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INSTRUMENT NEEDLES BECAME BROKEN DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076581 ↗
• MalfunctionMay 5, 2026Break

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INSTRUMENT NEEDLES BECAME BROKEN DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076579 ↗
• MalfunctionSep 30, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, AFTER 4¿5 ATTEMPTS, THE BUTTON FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23177876 ↗
• MalfunctionSep 2, 2025Break; Break

  A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN EVERY TIME THEY TRIED TO USE IT, BUT THEY COULDN'T RETRIEVE ANY CORE SAMPLES. THEY BELIEVE THE PROBLEM WASN'T CAUSED BY DENSE TISSUE AND ARE WORRIED ABOUT THE NEEDLE¿S QUALITY. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929852 ↗
• MalfunctionSep 2, 2025Break; Break

  A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN EVERY TIME THEY TRIED TO USE IT, BUT THEY COULDN¿T RETRIEVE ANY CORE SAMPLES. THEY BELIEVE THE PROBLEM WASN¿T CAUSED BY DENSE TISSUE AND ARE WORRIED ABOUT THE NEEDLE¿S QUALITY. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929846 ↗
• MalfunctionAug 28, 2025Break; Break

  A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN EVERY TIME THEY TRIED TO USE IT, BUT THEY COULDN¿T RETRIEVE ANY CORE SAMPLES. THEY BELIEVE THE PROBLEM WASN¿T CAUSED BY DENSE TISSUE AND ARE WORRIED ABOUT THE NEEDLE¿S QUALITY. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910750 ↗
• MalfunctionAug 28, 2025Break; Break

  A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN EVERY TIME THEY TRIED TO USE IT, BUT THEY COULDN'T RETRIEVE ANY CORE SAMPLES. THEY BELIEVE THE PROBLEM WASN'T CAUSED BY DENSE TISSUE AND ARE WORRIED ABOUT THE NEEDLE¿S QUALITY. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910749 ↗
• MalfunctionAug 28, 2025Break; Break

  A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN EVERY TIME THEY TRIED TO USE IT, BUT THEY COULDN'T RETRIEVE ANY CORE SAMPLES. THEY BELIEVE THE PROBLEM WASN'T CAUSED BY DENSE TISSUE AND ARE WORRIED ABOUT THE NEEDLE¿S QUALITY. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910747 ↗
• MalfunctionMar 28, 2025Difficult to Insert; Device Contamination with Chemical or Other Material; Material Twisted/Bent; Difficult to Insert; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY CROOKED. WE THEN SWITCHED TO A DIFFERENT BIOPSY NEEDLE, AFTER WHICH THE GRID SEEMED TO BE PASSABLE AND THE LAST BIOPSIES COULD STILL BE TAKEN. NEVERTHELESS, WE AGAIN FOUND PIECES OF PLASTIC IN THE BIOPSIES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719111 ↗
• MalfunctionFeb 28, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ECHOGRAPHY GUIDED PROSTATE BIOPSY THROUGH NORMAL DENSITY TISSUE, THE TIP OF THE NEEDLE WAS ALLEGEDLY FOUND TO BE BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. 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 21487619 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROSTATE BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12621639 ↗