MARQUEE MQK1213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741097270), received between Nov 21, 2016 and Nov 21, 2016 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2016Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRA SOUND GUIDED BREAST BIOPSY INTO HETEROGENEOUSLY DENSE TISSUE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE BREAST TISSUE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117468 ↗