MAGNUM MN1825Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741084362), received between Aug 27, 2018 and Sep 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  A patient underwent biopsy procedure using Magnum instrument. During the procedure, it was noticed that instrument needle was broken. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895425 ↗
• MalfunctionSep 8, 2026Break

  On (b)(6) 2026, a patient underwent an ultrasound guided prostate biopsy procedure through normal tissue density using the Magnum instrument. During the procedure, one needle broke during the 12th tissue collection, and another needle broke at the beginning of the procedure. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50665189 ↗
• MalfunctionDec 16, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL USING MAGNUM DEVICE. DURING THE PROCEDURE, THE DEVICE HAD A HUB BRAKE. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815011 ↗
• MalfunctionJun 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FOREIGN BODY (LINT). THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139110 ↗
• MalfunctionDec 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY THROUGH NORMAL DENSITY ISSUE, THE NEEDLE'S GAUGE ALLEGEDLY BECAME LOOSE FROM THE METAL PART. A COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21010696 ↗
• MalfunctionNov 29, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808542 ↗
• MalfunctionNov 29, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808541 ↗
• MalfunctionNov 29, 2024Break; 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 20808510 ↗
• MalfunctionMar 30, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947167 ↗
• MalfunctionDec 24, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTRATE BIOPSY PROCEDURE, THE OUTER NEEDLE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13083459 ↗
• MalfunctionJul 22, 2019Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MN1825 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND MATERIAL TWISTING. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE TWO MALFUNCTIONS BOTH INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. THE PATIENTS WERE BOTH REPORTED AS MALES; THE PATIENTS¿ AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813631 ↗
• MalfunctionApr 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL MN1825 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FOREIGN MATERIAL IN THE STERILE PACKAGING. IT WAS FURTHER REPORTED THE DEVICE WAS NOT OPENED AND WAS DISCARDED AT THE FACILITY. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8520290 ↗
• MalfunctionAug 27, 2018Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED PROSTATE BIOPSY IN NORMAL DENSITY TISSUE, AFTER DELIVERING ANESTHESIA THROUGH THE CANNULA OF THE NEEDLE, THE OPERATOR ALLEGEDLY FOUND THE CANNULA DIFFICULT TO REMOVE FROM THE PATIENT. REPORTEDLY, UPON REMOVAL FROM THE PATIENT, THE CANNULA WAS BENT A FEW CENTIMETERS FROM THE TIP. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820787 ↗