Tru-Core II URO Biopsy InstrumentRecalls & reported problems across all models

We found 2 models of Tru-Core II URO Biopsy Instrument by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (2 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tru-Core II URO Biopsy Instrument recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Tru-Core II URO Biopsy Instrument problems

Tru-Core II URO Biopsy Instrument models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tru-Core™ II URO Biopsy Instrument 763418200X

  Instrument, Biopsy
  1 recall2 reports
• Tru-Core™ II URO Biopsy Instrument 763418250X

  Instrument, Biopsy
  1 recall0 reports

Recent Tru-Core II URO Biopsy Instrument adverse event reports

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

• InjuryJul 2, 2024Defective Device; Defective Device

  REPORTER INDICATED "HIGH NUMBER OF REVISIONS FOR RECTAL BLEEDING FOLLOWING THE USE OF THESE BIOPSY NEEDLES PROSTATE (5 IN 1 MONTH, 3 DIFFERENT OPERATORS).FOR THE UROLOGY TEAM, THE BEVEL IS REVERSED ON THESE NEEDLES. THIS CAN CAUSE INJURY AND BLEEDING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19662719 ↗
• MalfunctionJul 2, 2024Defective Device; Defective Device

  THE REPORTER INDICATED "HIGH NUMBER OF REVISIONS FOR RECTAL BLEEDING FOLLOWING THE USE OF THESE BIOPSY NEEDLES PROSTATE (5 IN 1 MONTH, 3 DIFFERENT OPERATORS).FOR THE UROLOGY TEAM, THE BEVEL IS REVERSED ON THESE NEEDLES. THIS CAN CAUSE INJURY AND BLEEDING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19662680 ↗

Other Argon Medical Devices, Inc. products

• First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
• BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
• BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
• L-Cath PICC S/L2 models · 30 reports · 1 recall
• Tru-Core II Biopsy Instrument8 models · 13 reports · 1 recall
• Scorpion2 models · 7 reports · 1 recall
• Arterial Line Kit2 models · 2 reports · 1 recall
• Transvenous Pacing Electrode Tray2 models · 0 reports · 1 recall