MARQUEE MQK1825Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741097379), received between Nov 17, 2017 and Apr 27, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break; Failure to Obtain Sample; Firing Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MARQUEE DEVICE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY MISFIRED AND FAILED TO OBTAIN A SAMPLE. IT WAS FURTHER REPORTED THAT A PART OF THE DEVICE CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994263 ↗
• MalfunctionApr 27, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING THE MARQUEE DEVICE. POST THE PROCEDURE, THERE WAS INCREASED RECTAL BLEEDING. REPORTEDLY, THE BLEEDING WAS CONTROLLED PRIOR TO DISCHARGE FROM THE CLINIC. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994070 ↗
• MalfunctionMar 5, 2026Difficult to Remove

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MARQUEE DEVICE. DURING THE PROCEDURE, THE STYLET COULDN'T T BE PULLED OUT AFTER INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516894 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ULTRASOUND / MRI GUIDED PROSTATE BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT RECTAL BLEEDING AFTER HIS BIOPSY. NO COAXIAL NEEDLE WAS USED. REPORTEDLY, UNABLE TO COMPLETE THE PROCEDURE. FURTHERMORE, BLEEDING CONTINUED POST PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23904864 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ULTRASOUND / MRI GUIDED PROSTATE BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT RECTAL BLEEDING AFTER HIS BIOPSY. NO COAXIAL NEEDLE WAS USED. REPORTEDLY, UNABLE TO COMPLETE THE PROCEDURE. FURTHERMORE, BLEEDING CONTINUED POST PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23904854 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PROSTATE BIOPSY PROCEDURE USING THE MARQUEE DEVICE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT RECTAL BLEEDING. NO COAXIAL NEEDLE WAS USED. REPORTEDLY, UNABLE TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23813883 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PROSTATE BIOPSY PROCEDURE USING THE MARQUEE DEVICE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT RECTAL BLEEDING. NO COAXIAL NEEDLE WAS USED. REPORTEDLY, UNABLE TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23813877 ↗
• MalfunctionOct 22, 2025Break; Difficult to Remove; Dull, Blunt; Break; Difficult to Remove; Dull, Blunt

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING THE MARQUEE KIT. DURING THE PROCEDURE, THE NEEDLE BECAME STUCK IN THE RECTAL PROBE GUIDE. THERE WAS SIGNIFICANT DIFFICULTY IN REMOVAL, AND THE TIP OF THE GUN APPEARED TO BE BROKEN. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, AND CONSIDERABLE TRACTION WAS REQUIRED TO EXTRACT THE EQUIPMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355906 ↗
• MalfunctionNov 17, 2017Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ULTRASOUND-GUIDED PROSTATE BIOPSY IN NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY SELF-ACTIVATED OUTSIDE OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041937 ↗