MAGNUM MN1820Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741084355), received between Jun 14, 2018 and May 11, 2026 — classified as 19 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16, 2026.

Recalls naming this device

1. Aug 2, 2024Open, Classified

   Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.

   Z-3206-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134353 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134352 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134350 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134347 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134346 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134345 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134344 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134343 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134342 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134341 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134340 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134339 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134337 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134335 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 25134334 ↗
• MalfunctionApr 7, 2026Break

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797870 ↗
• MalfunctionOct 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT PREPARED FOR A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THERE WAS SMALL AMOUNT OF DIRT DISCOVERED IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23241963 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771019 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771016 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21016702 ↗
• MalfunctionOct 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROSTATE BIOPSY PROCEDURE, THE FOURTH NEEDLE ALLEGEDLY BEING TAKEN OUT WHILE THE DEVICE STOPPED WORKING. IT WAS FURTHER REPORTED THAT WHEN THE NEEDLE WAS REMOVED, THE PINK PART WAS ALLEGEDLY DAMAGED. FURTHERMORE, THE STYLET ALLEGEDLY DETACHED FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468128 ↗
• MalfunctionJul 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE WAS ALLEGEDLY CONTAMINATED WITH FOREIGN BODIES IN THE PACKAGE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657009 ↗
• MalfunctionJul 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE, A FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE NEEDLE NOTCH OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377042 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING. A COAXIAL WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. RIGHT AFTER THE BIOPSY, A RECTORRHAGIA OCCURRED THAT DID NOT SUBSIDE AND REQUIRED THE PERFORMANCE OF A RECTOSCOPY, IN WHICH A HEMOSTATIC INJECTION OF SIX CC OF ADRENALINE WAS GIVEN AND FOUR CLIPS WERE PLACED TO CONTROL THE BLEEDING. THE PATIENT WAS SUBSEQUENTLY DISCHARGED AFTER TWENTY-FOUR HOURS OF OBSERVATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16939203 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PATIENT EXPERIENCED BLEEDING. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. DURING THE BIOPSY, A PROFUSE RECTORRHAGIA WAS UNABLE TO BE CONTROLLED WITH A FEW MINUTES OF COMPRESSION OF THE PROSTATE WITH THE TRANSDUCER, INTERRUPTING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT IN STABLE CONDITION BUT WITH ACTIVE BLEEDING IN THE ANAL AREA. URGENT RECTOSCOPY WAS PERFORMED IN WHICH SEVERAL PUNCTATE LESIONS WERE VISUALIZED CORRESPONDING TO THE PUNCTURE SITES, ONE WITH A CLOT. TWO CLIPS WERE PLACED THERE. THE PATIENT WAS KEPT UNDER OBSERVATION IN STABLE CONDITION. NO NEW RECTAL BLEEDING APPEARED THUS THE PATIENT WAS DISCHARGED AFTER 24 HOURS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16939198 ↗