Disposable Biopsy Needle 41778CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048223029503), received between Nov 15, 2019 and Mar 17, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). TENTATIVE TRANSLATION FROM INITIAL REPORTERS NARRATIVE: THE SURGEON REPORTED THAT THERE WERE SEVERE COMPLICATIONS AFTER BIOPSY OPERATION. AFTERWARDS THE PATIENT HAD A NEUROLOGICAL DEFICIT AND WAS 13 DAYS IN-HOUSE (INSTEAD 1-2 DAYS NORMALLY). NEGATIVE EFFECT EXPLANATION: MASSIVE BLEEDING.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13802692 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRN#:070_3-22_749. THE SURGEON REPORTED THAT THERE WERE SEVERE COMPLICATIONS AFTER A BIOPSY CASE. WHILE THE BIOPSY THEY DID NOT RECOGNIZE ANY ISSUES OR ABNORMALITIES. NEGATIVE EFFECT EXPLANATION: MASSIVE BLEEDING INTO THE TUMOR TISSUE WITH REDUCTION OF THE VIGILANCE. FURTHERMORE, THEY EXPECT OTHER DEFICITS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13802689 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRN#:(B)(4). THE SURGEON REPORTED THAT THERE WERE SEVERE COMPLICATIONS AFTER BIOPSY OPERATION. NEGATIVE EFFECT EXPLANATION: BLEEDING OF THE THALAMUS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13802687 ↗
• MalfunctionNov 15, 2019Difficult to Open or Close; Difficult to Open or Close

  IRN#: (B)(4). USER FACILITY REPORT NUMBER: (B)(4).DESCRIBE THE EVENT OR PROBLEM: OR . PERFORMED A STEREOTACTIC BIOPSY ON THIS PT WHERE HE USES THE DISPOSABLE BIOPSY NEEDLE KIT. REF# (B)(4). BIOPSY NEEDLE MALFUNCTIONED . THE TIP WAS NOT OPENING AND CLOSING AS INSTRUCTED ON PORT. DRS DID TROUBLESHOOT THE ISSUE AND NOTED IT WAS NOT FUNCTIONING PROPERLY. DID NOT USE THIS BIOPSY NEEDLE ONCE NOTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: STEREOTACTIC BIOPSY. VLHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;THE DEVICE IS MANUFACTURED BY (B)(4) GMBH MEDIZINTECHNOLOGIE EXCLUSIVELY FOR BRAINLAB AG AND DISTRIBUTED THROUGH BRAINLAB IN THE UNITED STATES OF AMERICA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9325687 ↗