Biopsy Forceps 504300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032056090), received between Aug 27, 2021 and Jun 2, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2023Fracture; Fracture

  AS REPORTED, AFTER OPENING A 5.5F 104CM STANDARD BIOPSY FORCEPS THE DEVICE WAS FOUND FRACTURED INTO THREE PARTS. ANOTHER 5.5F 104CM STANDARD BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049553 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, WHILE USING A 5.5F 104CM STANDARD BIOPSY FORCEPS, THE RIGHT ATRIUM WAS PERFORATED. CONSERVATIVE THERAPY WAS TAKEN, AND THE PATIENT HAS BEEN FOLLOWED UP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: Cardiac Perforation

  MAUDE report 15451257 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE LITERATURE ARTICLE BY TYLER Z, GUTTMANN OP, DHINOJA M, ORO R, SAVVATIS K, MOHIDDIN S, SEKHRI N, LOPES L, PATEL V, JONES DA, BOURANTAS CV, MATHUR A, ELLIOTT PM, O'MAHONY C. THE SAFETY AND FEASIBILITY OF TRANSITIONING FROM TRANSFEMORAL TO TRANSRADIAL ACCESS LEFT VENTRICULAR ENDOMYOCARDIAL BIOPSY. J INVASIVE CARDIOL. 2020 DEC; 32(12):E349-E354. EPUB 2020 NOV 10. PMID: 33168780. ONE PATIENT DEVELOPED CARDIAC TAMPONADE AFTER 3 BIOPSIES WERE TAKEN WITH A 5F, 104 CM CORDIS BIOPTOME BIOPSY FORCEPS VIA THE RIGHT FEMORAL ARTERY. PERICARDIOCENTESIS WAS PERFORMED WITHOUT THE NEED FOR SURGERY AND THE PATIENT HAD AN UNEVENTFUL RECOVERY. THE CORDIS BIOPTOME WAS THEN ADVANCED THROUGH THE UNKNOWN MP GUIDE CATHETER INTO THE LEFT VENTRICULAR (LV) CAVITY. SAMPLES WERE OBTAINED WITH FLUOROSCOPIC GUIDANCE. REPETITIVE BLEED-BACK AND MANUAL FLUSHING WERE UNDERTAKEN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 12376909 ↗