MAX-CORE MC2016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741084515), received between Oct 11, 2017 and Aug 26, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062479 ↗
• InjuryApr 2, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN CT GUIDED LUNG BIOPSY PROCEDURE, THE GUN WAS ALLEGEDLY JAMMED AND COULD NOT BE RETURNED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY SUFFERED PNEUMOTHORAX. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 19021778 ↗
• MalfunctionJan 30, 2023Failure to Prime; Self-Activation or Keying; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING A CT GUIDED LUNG BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263921 ↗
• MalfunctionMar 2, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY, THE DEVICE ALLEGEDLY SELF ACTIVATED. A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397508 ↗
• MalfunctionOct 23, 2020Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample; Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MC2016 BIOPSY INSTRUMENT EXPERIENCED FAILURE TO PRIME, FAILURE TO OBTAIN SAMPLES, SELF ACTIVATION AND NEEDLE BENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731266 ↗
• MalfunctionJul 17, 2020Unsealed Device Packaging; Unsealed Device Packaging

  THIS REPORT SUMMARIZES FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MC2016 BIOPSY INSTRUMENT ALLEGEDLY HAD PACKAGING PEELED OPEN. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD NO PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10292586 ↗
• MalfunctionJul 16, 2020Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MC2016 BIOPSY INSTRUMENT ALLEGEDLY BENT AND WAS DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A (B)(6) YEARS OLD MALE AND WEIGHED (B)(6) KG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287329 ↗
• MalfunctionOct 11, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION FOR A BIOPSY, THE DEVICE ALLEGEDLY FIRED WITHOUT THE USER SELECTING THE TRIGGER. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6942321 ↗