MAGNUM MN1213Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAGNUM® Disposable Core Tissue Biopsy Needle, 12g x 13cm · Class 2
Quick summary
This Bard Magnum biopsy needle is a disposable needle used to take small tissue samples, often in breast biopsies. The 42 reports mostly describe the needle or a plastic part breaking during or before the procedure, with procedures finished using another needle and no deaths and no injuries mentioned. No recalls name this device. Reports fell to 1 in the most recent year from 17 the year before.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741084218), received between Oct 18, 2022 and Sep 2, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Break” (42 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
- Break42
- Failure to Obtain Sample8
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Break
A patient underwent a biopsy procedure using a Magnum instrument. During the procedure, it was reported that the cannula hub was fractured and/or crumbled, compromising its integrity and preventing the procedure from being safely continued. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560492 ↗MalfunctionNov 25, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT MAMMOGRAPHY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE, THE PLASTIC PART OF THE DEVICE WAS BROKEN. 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 23641571 ↗MalfunctionAug 19, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE BREAST BIOPSY PROCEDURE USING THE MAGNUM INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22838349 ↗MalfunctionAug 19, 2025Break; Break
ON (B)(6) 2025, A PATIENT PREPPED FOR A BREAST BIOPSY PROCEDURE USING THE MAGNUM. PRIOR THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE BREAK. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836825 ↗MalfunctionJun 13, 2025Break; Break
ON (B)(6) 2024 A PATIENT UNDERWENT THE BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BREAKS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202774 ↗MalfunctionJun 11, 2025Break; Break
ON (B)(6) 2024, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182475 ↗MalfunctionJun 11, 2025Break; Break
ON (B)(6) 2024, A PATIENT UNDERWENT THE BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182324 ↗MalfunctionJun 11, 2025Break; Break
ON (B)(6) 2024 A PATIENT UNDERWENT THE BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BREAKS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182067 ↗MalfunctionJun 11, 2025Break; Break
ON (B)(6) 2024 A PATIENT UNDERWENT THE BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BREAKS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182063 ↗MalfunctionJun 11, 2025Break; Break
ON (B)(6) 2024 A PATIENT UNDERWENT THE BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BREAKS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182062 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572464 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572163 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569932 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569930 ↗MalfunctionFeb 14, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE WHEN THE DRIVER WAS CLOSED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21382408 ↗MalfunctionFeb 14, 2025Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE WHEN THE DRIVER WAS CLOSED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21382332 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672834 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672821 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672817 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531794 ↗MalfunctionAug 12, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER FIRING THE NEEDLE WITH THE GUN, IT WAS NOT POSSIBLE TO FIRE A SECOND SHOT AND COLLECT THE FRAGMENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY BROKEN INSIDE THE INSTRUMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958817 ↗MalfunctionAug 12, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER FIRING THE NEEDLE WITH THE GUN, IT WAS NOT POSSIBLE TO FIRE A SECOND SHOT AND COLLECT THE FRAGMENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY BROKEN INSIDE THE INSTRUMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958816 ↗MalfunctionJul 22, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19802544 ↗MalfunctionJul 22, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19802013 ↗MalfunctionMay 29, 2024Break; Failure to Obtain Sample; Break; Failure to Obtain Sample
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER FIRING THE NEEDLE WITH THE DEVICE, THE DEVICE ALLEGEDLY FAILED TO FIRE A SECOND SHOT AND IT COULD NOT COLLECT THE FRAGMENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS OPENED AND THE NEEDLE WAS ALLEGEDLY FOUND TO BE BROKEN INSIDE THE INSTRUMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19412944 ↗
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- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.