MAGNUM MN1210Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAGNUM® Disposable Core Tissue Biopsy Needle, 12g x 10cm · Class 2
All models of MAGNUM (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the Bard Magnum MN1210 disposable core tissue biopsy needle, a 12-gauge needle used to take tissue samples, most often in breast biopsies. The 29 reports mostly describe the needle breaking during the procedure, sometimes in its blue plastic piece, and one report describes use in a way that did not go as intended. None of the reports describe a death or an injury. No recalls name this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741084201), received between Apr 27, 2022 and Sep 28, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (27 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break27
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
On (b)(6) 2026, a patient underwent a biopsy procedure using a Magnum Needle. During the procedure, the needle was broken. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912645 ↗MalfunctionApr 10, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM DEVICE. DURING THE PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843649 ↗MalfunctionApr 10, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM DEVICE. DURING THE PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838904 ↗MalfunctionApr 10, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDE BREAST BIOPSY PROCEDURE VIA HARD DENSITY TISSUE USING THE MAGNUM. DURING THE PROCEDURE, THE DEVICE BLUE PLASTIC PIECE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838903 ↗MalfunctionFeb 16, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, THE DEVICE NEEDLE BREAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342748 ↗MalfunctionSep 9, 2025Break; Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, THE DEVICE NEEDLE BREAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001614 ↗MalfunctionAug 13, 2025Break; Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY BREAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790800 ↗MalfunctionApr 30, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932065 ↗MalfunctionFeb 3, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FATTY TISSUE, THE HUB WAS ALLEGEDLY BROKEN. 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 21300573 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE ALLEGEDLY BROKE INTO FOUR PIECES INSIDE THE PATIENT. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20840563 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE ALLEGEDLY BROKE INTO FOUR PIECES INSIDE THE PATIENT. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20840494 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE ALLEGEDLY BROKE INTO FOUR PIECES INSIDE THE PATIENT. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20840492 ↗MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE BROKE. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832291 ↗MalfunctionSep 3, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, IT WAS FOUND THAT THE BIOPSY WAS NOT PERFORMED WELL, SO THE PROBE WAS EXAMINED AND WHEN OPENED, IT WAS FOUND THAT THE NEEDLE WAS ALLEGEDLY BROKEN. NO 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 20124392 ↗MalfunctionSep 3, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, IT WAS NOTICED THAT BIOPSY WAS NOT PERFORMED WELL. IT WAS FURTHER REPORTED THAT THE PROBE WAS EXAMINED AND WHEN OPENED IT NOTICED THAT THE NEEDLE WAS ALLEGEDLY BROKEN. NO 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 20124238 ↗MalfunctionJun 3, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STYLET WAS ALLEGEDLY DETACHED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19445237 ↗MalfunctionJun 3, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STYLET WAS ALLEGEDLY DETACHED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19445207 ↗MalfunctionJun 3, 2024Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STYLET WAS ALLEGEDLY DETACHED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19445206 ↗MalfunctionJan 5, 2024Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE PLASTIC PART OF THE PROBE WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449882 ↗MalfunctionJul 10, 2023Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE PLASTIC HUB ALLEGEDLY BROKE OUTSIDE OF THE PATIENT. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17286234 ↗MalfunctionJun 26, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BROKEN AT THE TIME OF SHOOTING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17198920 ↗MalfunctionApr 24, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE AT THE TIME OF THE INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16793268 ↗MalfunctionApr 24, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE AT THE TIME OF THE INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16793193 ↗MalfunctionMar 30, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THROUGH NORMAL DENSITY, THE NEEDLE OF THE DEVICE ALLEGEDLY BROKEN WHILE FIRING. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16641564 ↗MalfunctionMar 30, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE ALLEGEDLY BROKEN WHILE FIRING. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16641509 ↗
Other Biopsy needle devices
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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