MARQUEE MQ1810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741097195), received between Oct 14, 2024 and Sep 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED LYMPH NODE BIOPSY USING THE MARQUEE KIT. DURING THE PROCEDURE, THE STYLET ALLEGEDLY WAS FOUND BENT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO 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 23131312 ↗
• MalfunctionSep 23, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED LYMPH NODE BIOPSY USING THE MARQUEE KIT. DURING THE PROCEDURE, THE STYLET ALLEGEDLY WAS FOUND BENT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO 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 23119949 ↗
• MalfunctionSep 23, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED LYMPH NODE BIOPSY USING THE MARQUEE KIT. DURING THE PROCEDURE, THE STYLET ALLEGEDLY WAS FOUND BENT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO 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 23119453 ↗
• MalfunctionOct 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE FOREIGN MATERIAL WAS INSIDE THE CHAMBER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447281 ↗