MAGNUM MN2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741084416), received between Mar 16, 2022 and Mar 24, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE UPON OPENING THE PACKAGE, A FOREIGN MATERIAL LIKE BLACK SPOT WAS ALLEGEDLY OBSERVED IN THE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611213 ↗
• MalfunctionMar 15, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS PULLED OUT WITH A STRONG FORCE FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544345 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL TISSUE, THE NEEDLE ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT HEALTHCARE PERSONNEL PULLED OUT THE NEEDLE WITH STRONG FORCE WHILE REMOVING FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495863 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ALLEGEDLY PULLED OUT THE NEEDLE WITH STRONG FORCE FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495850 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS PULLED OUT WITH A STRONG FORCE FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495847 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS PULLED OUT WITH A STRONG FORCE FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494054 ↗
• MalfunctionMar 16, 2022Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PROSTATE BIOPSY, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE DEVICE NEEDLE WAS ALLEGEDLY FOUND BENT. A COAXIAL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13785632 ↗