MAGNUM MN1610Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741084287), received between Jan 9, 2018 and Sep 8, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Device Contamination with Chemical or Other Material

  On (b)(6), 2026, a patient underwent biopsy procedure using Magnum needle. Prior to the procedure, it was noticed that foreign matter was found in the needle while opening the package. The procedure was completed by another device. There was no reported patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50664008 ↗
• MalfunctionMay 12, 2025Device Markings/Labelling Problem; Device-Device Incompatibility; Device Markings/Labelling Problem; Device-Device Incompatibility

  A PATIENT UNDERWENT A CT GUIDED BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, IT WAS NOTED THE NEEDLES WERE DIFFERENT SIZES, WHICH COMPROMISES THE PLANNING AND SAFETY OF THE PROCEDURES DESPITE BEING THE SAME MAKE, MODEL AND NUMBER. REPORTEDLY IN ADDITION TO THE SIZE INCOMPATIBILITY, THE NEEDLE BASE (PINK PART) WAS DISCONNECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000452 ↗
• MalfunctionMay 7, 2024Break; Failure to Obtain Sample; Break; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DID NOT GO DOWN. IT WAS FURTHER REPORTED THAT SOME PARTS WERE ALLEGEDLY BROKEN. THE PROCEDURE COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257629 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE ALLEGEDLY GOT BROKEN. A COAXIAL NEEDLE WAS NOT 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 17948160 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO PRIME UPON REMOVING THE SAMPLE FROM THE DEVICE. IT WAS FURTHER REPORTED THAT PLASTIC HUB WAS ALLEGEDLY FOUND CRACKED IN THE DEVICE. REPORTEDLY, THE DEVICE SUCCESSFULLY PRIMED ONCE THE BROKEN SEGMENTS WERE REMOVED FROM THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832126 ↗
• MalfunctionJun 29, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17223929 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518591 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518470 ↗
• MalfunctionJan 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR A BIOPSY, AN ALLEGED FOREIGN MATERIAL WAS FOUND BETWEEN THE CANNULA AND STYLET. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7175887 ↗