MAX-CORE MC2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741084522), received between Jul 23, 2020 and Dec 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. Oct 25, 2019Terminated

   During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

   Z-0724-2020 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT WHILE PENETRATING THE TISSUE. IT WAS FURTHER REPORTED THAT COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. REPORTEDLY, THE NEEDLE WAS PULLED OUT FROM PROSTATE BY FORCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325265 ↗
• MalfunctionJul 23, 2020Unsealed Device Packaging; Unsealed Device Packaging

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED MALFUNCTIONS INDICATED THAT MODEL MC2020 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED UNSEALED DEVICE PACKAGING. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE MALFUNCTIONS DID NOT INVOLVE WITH PATIENTS AS THERE WAS NO PATIENT CONTACT. THE PATIENTS' AGE, GENDER AND WEIGHT WERE NOT PROVIDED FOR ALL THREE MALFUNCTIONS.

  Patient problems: No Patient Involvement

  MAUDE report 10314975 ↗