MARQUEE MQ1413Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741097140), received between Jun 29, 2020 and Jun 3, 2021 — classified as 3 injuries, 1 malfunction.

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. 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.

• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY HAD PNEUMOTHORAX. PATIENT REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929193 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH ANONYMOUS POST-MARKET CLINICAL FOLLOW-UP SURVEY ON CORE BIOPSY INSTRUMENTS, THERE WAS ONE OCCURRENCE OF THORACOSTOMY TUBE PLACEMENT. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 11810995 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE BUTTON ALLEGEDLY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492235 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON BIOPSIES, TWO PATIENTS EXPERIENCED HEMORRHAGE WITH COMPLICATIONS. THE CURRENT PATIENTS' STATUS IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10210118 ↗