MAGNUM MN1410Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAGNUM® Disposable Core Tissue Biopsy Needle, 14g x 10cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Bard Magnum core biopsy needle has 119 adverse event reports, with 5 injuries and no deaths. Many describe the needle breaking, bending or being hard to remove during biopsies. Reports fell from 65 in the prior 12 months to 20 in the last 12 months. 1 recall is open, from August 2024, over packaging damage that may compromise the sterile barrier.
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
- 118
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00801741084249), received between Jul 12, 2019 and Sep 2, 2026 — classified as 5 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Break” (75 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Break75
- Device Contamination with Chemical or Other Material20
- Material Twisted/Bent20
- Difficult to Remove14
- Detachment of Device or Device Component7
- Device Markings/Labelling Problem6
- Failure to Obtain Sample2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Hemorrhage/Blood Loss/Bleeding3
- No Consequences Or Impact To Patient3
- Pain1
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Break
On (b)(6) 2026, a patient underwent biopsy procedure using Magnum instrument. During the procedure, it was noticed that the instrument needle was broken. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560470 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520469 ↗MalfunctionApr 10, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A MAGNUM INSTRUMENT. DURING THE PROCEDURE, AT THE TIME OF PRIME LOADING OF THE MAGNUM NEEDLE, THE DRIVER DID NOT LOAD THE NEEDLE. IT WAS FURTHER REPORTED THAT THE MAGNUM NEEDLE BROKE DURING PRIME LOADING, WITH GREEN PIECES REMAINING INSIDE THE DRIVER, CAUSING IT TO JAM AND FAIL TO FUNCTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24842119 ↗MalfunctionMar 31, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING A MAGNUM NEEDLE. DURING THE PROCEDURE, THE NEEDLE ALLEGEDLY BENT INSIDE THE PATIENT, MAKING IT DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE DOUBLE NEEDLE REQUIRED MANIPULATION OF THE BREAST TO REMOVE THE NEEDLE, WHICH RESULTED IN INCREASED PAIN AND BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24742715 ↗MalfunctionMar 30, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE NEEDLE TIP WAS BENT, WHICH PREVENTED ITS REMOVAL. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728343 ↗MalfunctionFeb 26, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE USING THE MAGNUM DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE WAS ALLEGEDLY FOUND TO BE BENT. ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE WAS SLIGHTLY DIFFICULT TO REMOVE FROM THE PATIENT, AS IT FELT A BIT STUCK, BUT IT WAS STILL SUCCESSFULLY REMOVED. 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 24451765 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330169 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330168 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330167 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330166 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330161 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330158 ↗MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material
A PATIENT UNDERWENT DISPOSABLE BIOPSY PROCEDURE USING MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, CONTAMINATION WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330155 ↗MalfunctionJan 8, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001723 ↗MalfunctionJan 8, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE, THE DEVICE COUPLING WAS BROKEN. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001047 ↗MalfunctionJan 8, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE THE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001044 ↗MalfunctionJan 8, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE USING MAGNUM DEVICE. DURING THE PROCEDURE, THE DEVICE COUPLING WAS BROKEN. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001038 ↗MalfunctionDec 24, 2025Break; Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING THE MAGNUM. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BREAKS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886480 ↗MalfunctionDec 18, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. DURING THE PROCEDURE THE DEVICE NEEDLE WAS BROKEN. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836026 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323002 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322925 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322649 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322644 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320497 ↗MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. PRIOR TO THE PROCEDURE, A FOREIGN OBJECT OR LINT WAS PRESENT IN THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320495 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.