MARQUEE MQK1210Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741097263), received between Jun 15, 2017 and Jun 20, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE MARQUEE NEEDLE BECAME LODGED IN THE PATIENT¿S BREAST TISSUE DUE TO INCOMPLETE CUTTING ACTION. AS A RESULT, THE PHYSICIAN HAD TO FORCIBLY REMOVE THE NEEDLE, AT WHICH POINT A PORTION OF SOFT TISSUE WAS OBSERVED HANGING FROM THE NEEDLE TIP. THIS CAUSED TISSUE TEARING AND LED TO A HEMORRHAGE THAT TOOK A PROLONGED TIME TO ACHIEVE HEMOSTASIS. THE BLEEDING WAS CONTROLLED THROUGH THE INJECTION OF LIGNOCAINE WITH ADRENALINE AND APPLICATION OF COMPRESSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22295108 ↗
• MalfunctionJan 8, 2024Break; Nonstandard Device; Self-Activation or Keying; Detachment of Device or Device Component; Break; Nonstandard Device; Self-Activation or Keying; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE WAS TEST FIRED BEFORE USING NEEDLE GUN COCKED, THE NEEDLE ALLEGEDLY SHOT OUT OF THE DEVICE ACROSS ROOM. REPORTEDLY, THE WHOLE STYLET NEEDLE ALLEGEDLY FLEW OUT OF THE DEVICE AND HIT THE WALL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464591 ↗
• MalfunctionSep 19, 2023Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY SPLIT INTO TWO FULL PIECES, WHEN THE NEEDLE WAS REMOVED FROM THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770634 ↗
• MalfunctionJan 8, 2022Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13200791 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150296 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13149591 ↗
• MalfunctionDec 1, 2021Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906635 ↗
• MalfunctionDec 1, 2021Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906538 ↗
• MalfunctionDec 1, 2021Difficult to Remove; Failure to Fire; Firing Problem; Difficult to Remove; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FIRING PROBLEM AND IT WAS FURTHER REPORTED THAT THE NEEDLE WAS CAUGHT IN THE TISSUE WHILE TRYING TO WITHDRAW THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906478 ↗
• MalfunctionApr 26, 2018Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY, THE DEVICE ALLEGEDLY WOULD NOT CONSISTENTLY PRIME. THE CANNULA REPORTEDLY RELEASED OCCASIONALLY WHEN PRIMING THE STYLET. IT WAS FURTHER REPORTED THAT THREE TISSUE SAMPLES WERE OBTAINED WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467224 ↗
• MalfunctionJun 15, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE FIVE PACK BOX, THE BOX ALLEGEDLY ONLY CONTAINED TWO DEVICES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6645561 ↗