Tru-Core™ II Biopsy Instrument 763120160XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333006571), received between Jul 21, 2022 and Oct 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

• MalfunctionOct 23, 2022Break; Entrapment of Device; Material Deformation

  MOVED TO A POSTERIOR APPROACH FOR THE NEXT ATTEMPT. AFTER IMAGING THEY NOTICED A SMALL METALLIC OBJECT FOR THE FIRST TIME AND WHEN HE LOOKED AT THE BIOPSY DEVICE HE NOTICED THE TIP MISSING AND SLIGHT DEFORMED LOOK. THE DEVICE ONLY HAD ONE PASS WHEN TIP BROKE OFF. THEY USED ANOTHER TRU CORE DEVICE SUCCESSFULLY. THE NODULE WAS NEAR RIB CAGE BONE AND IT IS A POSSIBILITY CONTACT TO BONE WAS MADE, BUT THE OPERATOR DID NOT FEEL ANY TACTILE FEEDBACK THAT SUGGESTED THIS. THE PATIENT SAW FURTHER EVALUATION TO SEE IF SURGICAL REMOVAL WAS NEEDED AND THE SURGEON ADVISED AGAINST IT. THE TIP IS IN THE PLURAL SPACE OF THE PATIENT. NOTE- UPON RECEIVING THE DEVICE, THE TIP IS BENT AT NEARLY A 90 DEGREE ANGLE. THE OPERATING DOCTOR SAID THIS TYPE OF BEND DID NOT OCCUR DURING THE PROCEDURE AND MUST HAVE HAPPENED AFTER HANDLING FOR THE PER. THE AREA OF FOCUS IS THE DISTAL TIP. ARGON 19G COAXIAL INTRODUCER MCXS2016TY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15656408 ↗
• MalfunctionJul 21, 2022Material Deformation; Therapeutic or Diagnostic Output Failure

  THE TIP OF THE NEEDLE IS DAMAGED AND THE TISSUE CANNOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075838 ↗