MARQUEE MQK1810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741097348), received between Jan 11, 2024 and Dec 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Failure to Fire; Failure to Fire

  A PATIENT UNDERWENT KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MARQUEE DEVICE. DURING THE PROCEDURE THE DEVICE DID NOT FIRE. FURTHER IT WAS REPORTED THAT DID NOT COLLECT SAMPLE. 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 23714735 ↗
• MalfunctionJan 11, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOSPY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. 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 18490636 ↗