Tru-Core™ II Biopsy Instrument 763116160XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333006601), received between Nov 23, 2020 and Jul 2, 2024 — classified as 2 injuries, 1 malfunction.

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

1 FDA recall record 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 2, 2024Class IIOpen, Classified

   Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

   Z-3192-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Firing Problem; Firing Problem

  IN AN ELECTIVE KIDNEY BIOPSY WITH A BIOPSY INSTRUMENT, THE FOLLOWING INCIDENT CAN BE REPORTED TODAY, THE TENSIONED BIOPSY NEEDLE WAS INSERTED INTO THE PATIENT. AFTER ACTIVATING THE TRIGGER MECHANISM, THE DEVICE FIRED A "SHOT" AS INTENDED. WHEN PULLING IT OUT, HOWEVER, THE SHIELD ABOVE THE NEEDLE WAS OPEN AND THE DEVICE COULD NOT BE TENSIONED AGAIN. THE BIOPSY CYLINDER WAS LOST, SO THE PATIENT WAS UNNECESSARILY SUBJECTED TO A INCREASED RISK BECAUSE IT HAD TO BE BIOPSIED AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 19662648 ↗
• InjuryJul 21, 2021Break; Therapeutic or Diagnostic Output Failure

  RENAL PUNCTURE WAS PERFORMED IN THREE PATIENTS, AND BLEEDING OCCURRED IN TWO PATIENTS; ANOTHER PATIENT WAS UNABLE TO TAKE OUT THE TISSUE AT THE FIRST PUNCTURE, AND THE NEEDLE IS DAMAGED. FOUR BP WERE REPLACED CONTINUOUSLY. AT THE FIFTH PUNCTURE, A LARGE AMOUNT OF BLEEDING AND NECROSIS OF THE RIGHT KIDNEY OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 12205158 ↗
• InjuryNov 23, 2020Device Markings/Labelling Problem

  FOLLOW UP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10889065 ↗