MARQUEE MQ1210Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741097119), received between Jul 19, 2019 and Mar 17, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 FDA recall records name this device's identifier, 1 still open.

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. Sep 30, 2024Open, Classified

   Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

   Z-0467-2025 · Root cause: Process change control · FDA record ↗

2. 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.

• MalfunctionMar 17, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE BY USING MARQUEE DEVICE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE ITEM ALLEGEDLY FELL APART WHILE SETTING UP. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615700 ↗
• MalfunctionJul 2, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MARQUEE. PRIOR THE PROCEDURE, THE DEVICE THE OUTER CANNULA FLEW OFF THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383117 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY, THE NEEDLE ALLEGEDLY CAME OUT OF THE WHITE PART OF THE DEVICE. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349671 ↗
• MalfunctionMay 20, 2024Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY, THE NEEDLE ALLEGEDLY CAME OUT OF THE WHITE PART OF THE DEVICE. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349638 ↗
• MalfunctionJun 20, 2022Self-Activation or Keying; Dull, Blunt; Self-Activation or Keying; Dull, Blunt

  IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF ACTIVATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741711 ↗
• MalfunctionMay 20, 2022Break; Self-Activation or Keying; Dull, Blunt; Break; Self-Activation or Keying; Dull, Blunt

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY EXPLODED WHEN IT WAS BEING PRIMED. IT WAS FURTHER REPORTED THAT THE TIP WAS ALLEGEDLY DO NOT FEEL AS SHARP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460652 ↗
• MalfunctionFeb 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, BLOOD WAS FOUND ON THE TIP OF THE NEEDLE WHEN OPENING STERILE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331186 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON CORE BIOPSY INSTRUMENTS, THERE WERE THREE OCCURRENCES OF PAIN DURING LYMPH NODE BIOPSY PROCEDURE(S). IT WAS FURTHER REPORTED THAT THE TREATMENT PROVIDED WAS PAINKILLERS. THE CURRENT STATUS OF THE PATIENT(S) WAS NOT PROVIDED.

  Patient problems: Pain

  MAUDE report 11277362 ↗
• MalfunctionJul 19, 2019Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT AN MQ1210 BIOPSY INSTRUMENT WAS ALLEGEDLY DIFFICULT TO REMOVE AND FAILED TO OBTAIN SAMPLES. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED TWO PATIENTS WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WERE NOT REPORTED FOR THE PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807753 ↗