MAGNUMRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MAGNUM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 571
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 1
We found 19 models of MAGNUM by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 571 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2016 and Sep 30, 2026 — classified as 36 injuries, 535 malfunctions.
The most frequently reported specific device problem is “Break” (238 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAGNUM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 2, 2024Class IIOpen, 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 · names 6 of these models · Recall details · FDA record ↗
Most reported MAGNUM problems
Device problems
- Break238
- Device Contamination with Chemical or Other Material100
- Self-Activation or Keying99
- Device Difficult to Setup or Prepare57
- Material Twisted/Bent50
- Difficult to Remove39
- Failure to Prime34
- Adverse Event Without Identified Device or Use Problem24
Patient problems
- No Clinical Signs, Symptoms or Conditions474
- No Consequences Or Impact To Patient32
- No Patient Involvement32
- Sepsis15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Foreign Body In Patient6
- Hemorrhage/Blood Loss/Bleeding4
- Pain3
MAGNUM models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAGNUM MN1410Biopsy needle1 recall118 reports
- MAGNUM MG1522INSTRUMENT, BIOPSY150 reports
- MAGNUM MN1820Biopsy needle1 recall37 reports
- MAGNUM MN1616Biopsy needle1 recall17 reports
- MAGNUM MN1813Biopsy needle60 reports
- MAGNUM MN1610Biopsy needle1 recall9 reports
- MAGNUM MN1420Biopsy needle1 recall7 reports
- MAGNUM MN1413Biopsy needle55 reports
- MAGNUM MN2010Biopsy needle1 recall0 reports
- MAGNUM MN1213Biopsy needle43 reports
- MAGNUM MN1210Biopsy needle27 reports
- MAGNUM MN1416Biopsy needle15 reports
- MAGNUM MN1825Biopsy needle13 reports
- MAGNUM MN2020Biopsy needle7 reports
- MAGNUM MN1816Biopsy needle6 reports
- MAGNUM MN1620Biopsy needle4 reports
- MAGNUM MN1216Biopsy needle1 report
- MAGNUM MN1613Biopsy needle1 report
- MAGNUM MN1810Biopsy needle1 report
Recent MAGNUM adverse event reports
The 15 most recent reports across all models, 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 28, 2026Self-Activation or Keying
A patient underwent a biopsy procedure using magnum driver. During the procedure, the driver self activated while retrieving the sample from the needle. Additionally, it was also clarified that the driver self activated outside the patient after the cocking slide locked at a half red or silver position. The device was then fully primed a second time; however, it clicked into place and subsequently released on its own. Tissue samples could still be collected, and no needle malfunction was reported. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914946 ↗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 ↗MalfunctionSep 25, 2026Break
A patient underwent biopsy procedure using Magnum instrument. During the procedure, it was noticed that instrument needle was broken. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895425 ↗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 ↗MalfunctionSep 8, 2026Break
On (b)(6) 2026, a patient underwent an ultrasound guided prostate biopsy procedure through normal tissue density using the Magnum instrument. During the procedure, one needle broke during the 12th tissue collection, and another needle broke at the beginning of the procedure. 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 50665189 ↗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 ↗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 ↗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 ↗MalfunctionAug 26, 2026Self-Activation or Keying; Naturally Worn
A patient underwent reusable biopsy procedure using Magnum. It was reported that the Magnum driver prematurely fires during cocking. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50446982 ↗MalfunctionJul 9, 2026Device Markings/Labelling Problem
ON JUNE 21, 2026, IT WAS REPORTED THAT DURING COMPLAINT INVESTIGATION OF THE MAGNUM DEVICE, THE IDENTIFICATION MARKINGS, INCLUDING PENETRATION DEPTH AND PATENT NUMBER, WERE FOUND TO BE UNREADABLE AND ILLEGIBLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25759713 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM NEEDLES FOR TRANSPERINEAL PROSTATE BIOPSIES CONDUCTED IN THE OPERATING ROOM. POST PROCEDURE THE PATIENT EXPERIENCED UROSEPSIS. THE PHYSICIAN CONCLUDED THAT THE UROSEPSIS MAY BE ASSOCIATED WITH THE USE OF MAGNUM NEEDLES, NOTING THAT THE BIOPSY GUN WAS STERILIZED AFTER EACH PROCEDURE AND THAT NEEDLES FROM DIFFERENT BATCHES WERE USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Sepsis
MAUDE report 25134353 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
- Dorado49 models · 387 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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