MARQUEE MQK1610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741097317), received between Mar 23, 2021 and Feb 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2024Nonstandard Device; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Nonstandard Device; Device-Device Incompatibility; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE BIOPSY GUN ALLEGEDLY WOULD NOT FIT DOWN THE INTRODUCER THAT WAS INCLUDED IN THE KIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755493 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY PROCEDURE, THE CAP OF THE INTRODUCER NEEDLE ALLEGEDLY CAME OFF LEAVING THE NEEDLE WITHIN THE INTRODUCER. REPORTEDLY, THE NEEDLE WAS RETRIEVED OUT OF THE INTRODUCER AND PROCEEDED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451350 ↗
• MalfunctionMar 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, INCORRECT PRODUCT FOUND INSIDE A BOX LABELED WITH THE CORRECT PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11549040 ↗