MAGNUM MN1413Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAGNUM® Disposable Core Tissue Biopsy Needle, 14g x 13cm · Class 2
Quick summary
This Bard Magnum biopsy needle is a disposable core tissue needle used to take samples, such as from the prostate or breast. The 51 reports mostly describe the needle or its hub breaking during use, sometimes inside the trigger gun, plus bent or twisted parts and needles that were hard to remove. There are no deaths and no injuries. No recalls name this device. Reports rose from 8 in the prior 12 months to 35 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741084256), received between Jan 11, 2022 and Sep 30, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Break” (43 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.
Reports received per month
Most reported problems
Device problems
- Break43
- Material Twisted/Bent10
- Difficult to Remove9
- Device Markings/Labelling Problem2
- Nonstandard Device1
- Self-Activation or Keying1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions55
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952608 ↗MalfunctionSep 23, 2026Break
On (b)(6) 2026, a patient underwent an ultrasound guided breast biopsy procedure via normal density tissue using the Magnum instrument. Prior to the procedure, the biopsy gun was tested without the needle and was found to be functioning properly. During the procedure, two tissue fragments were collected; however, the plastic hub of the needle subsequently broke, requiring replacement with another needle. 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 50868121 ↗MalfunctionSep 23, 2026Break
On (b)(6) 2026, a patient underwent biopsy procedure using the Magnum instrument. Prior to the procedure, the biopsy gun was tested without the needle and was found to be functioning properly. During the procedure, four tissue fragments were collected, however, the needle subsequently broke, requiring replacement with another needle. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866594 ↗MalfunctionSep 11, 2026Nonstandard Device; Device Markings/Labelling Problem; Material Twisted/Bent
On (b)(6) 2026, a patient underwent a Mammogram guided breast biopsy procedure through normal density tissue using the Magnum instrument. During the procedure, it was reported that the packaging was labeled as MN1413. However, the actual product received was MN1416. During use, the needle was longer than expected and contacted the mammography detector. Additionally, it was reported the needle observed to be bent. 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 50726035 ↗MalfunctionApr 15, 2026Break
ON (B)(6) 2026, A MALE PATIENT WAS PREPPED FOR A PROSTATE BIOPSY PROCEDURE BY USING THE MAGNUM INSTRUMENT. IT WAS REPORTED THAT PRIOR TO THE TEST PUNCTURE PHASE, THE DISPOSABLE BIOPSY NEEDLE REPORTEDLY SNAPPED. ADDITIONALLY, AFTER THE NEEDLE WAS ADVANCED, THE CANNULA ALLEGEDLY DID NOT RETRACT AS EXPECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882831 ↗MalfunctionMar 25, 2026Break; Self-Activation or Keying
A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING MAGNUM NEEDLE. DURING THE PROCEDURE, WHILE FITTING THE NEEDLE INTO THE TRIGGER DEVICE AND PERFORMING A PRE TEST, THE FITTING BROKE, CAUSING THE DEVICE TO FIRE UNEXPECTEDLY. AS A RESULT, THE NEEDLE PROJECTED INTO THE PATIENTS BREAST AT A LOCATION DIFFERENT FROM THE INTENDED BIOPSY SITE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684322 ↗MalfunctionFeb 10, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE HAS ALLEGEDLY BROKE, WHICH COULD HAVE INTERFERED WITH THE SURGEON SURGICAL MANEUVERS, DELAYED THE PROCEDURE, INCREASED SURGICAL TIME, AND INTERFERED WITH THE SURGERY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301768 ↗MalfunctionJan 5, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MAGNUM INSTRUMENT. DURING THE PROCEDURE, THE HUB OF THE DEVICE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955046 ↗MalfunctionDec 24, 2025Break; Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THENEEDLE WAS BROKEN. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886284 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764802 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764800 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764799 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764752 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754647 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754574 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754573 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754572 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754570 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754569 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754568 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754566 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754563 ↗MalfunctionDec 9, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLES ARE BREAKING INSIDE THE GUN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754562 ↗MalfunctionDec 8, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. DURING THE PROCEDURE THE NEEDLE WAS ALLEGED BROKEN INSIDE THE GUN. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23740950 ↗MalfunctionDec 8, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. DURING THE PROCEDURE THE NEEDLE WAS ALLEGED BROKEN INSIDE THE GUN. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739328 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.