TRU-CUT 2N2704XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403110627), received between Jul 22, 2020 and Aug 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A BREAST BIOPSY PROCEDURE THE PHYSICIAN INADVERTENTLY PENETRATED THE PATIENT'S BODY CAVITY WITH THE BIOPSY NEEDLE THUS RESULTING IN A PERICARDIAL EFFUSION AND TAMPONADE.

  Patient problems: No Information

  MAUDE report 10403530 ↗
• MalfunctionJul 22, 2020Retraction Problem

  A "TRU-CUT" WAS USED ON PATIENT FOR A LIVER BIOPSY. UPON REMOVAL OF INSTRUMENT AFTER ATTEMPTING TO GET SPECIMEN, IT WAS NOTICED THAT THE HANDLE WOULDN'T RETRACT. THE TRU-CUT WAS REMOVED IN ONE PIECE, NO PIECES LEFT IN PATIENT. ANOTHER TRU-CUT WAS GIVEN TO SURGEON AND USED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307383 ↗