MAGNUM MG1522Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00801741083945), received between Sep 29, 2016 and Sep 28, 2026 — classified as 1 injury, 149 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (98 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 24, 2026Failure to Fire; Missing Information

  IT WAS REPORTED THAT THE MAGNUM DRIVER IS NOT FIRING DURING THE PROCEDURE. ADDITIONAL CLARIFICATION WAS PROVIDED STATING THE MAGNUM DRIVER PRIMES SUCCESSFULLY BUT FAILS TO FIRE, THE TRIGGER MECHANISM IS NON FUNCTIONAL AND APPEARS TO BE JAMMED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED. ADDITIONALLY, ON THE VIDEO PROVIDED BY THE CUSTOMER DEMONSTRATING THE ISSUE WITH THIS DRIVER WITH NO PATIENT INVOLVEMENT, IT WAS OBSERVED THAT THE SERIAL NUMBER ETCHING IS MISSING ON THE MAGNUM DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976666 ↗
• MalfunctionApr 13, 2026Self-Activation or Keying

  THE PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. IT WAS REPORTED THAT THE MAGNUM DRIVER FIRES UNINTENTIONALLY DURING THE RELOADING PROCESS. IT WAS FURTHER REPORTED THAT FOLLOWING THE SECOND PRIME ATTEMPT, THE MAGNUM DRIVER DISCHARGED IMMEDIATELY AFTER THE USER REMOVED THEIR FINGER FROM THE PREPARATION MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854941 ↗
• MalfunctionFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Self-Activation or Keying

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING GAMMA FINDER, MAGNUM INSTRUMENT. IT WAS REPORTED THAT THE MAGNUM DEVICE FIRES SPONTANEOUSLY FROM TIME TO TIME. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS PROVIDED THAT THE BIOMED DISCOVERED DURING CLEANING OF THE MAGNUM DEVICE, IT WOULD FULLY LOCK INTO THE SECOND PRIMING POSITION SHOWING A FULL RED INDICATOR, WITH AN AUDIBLE CLICK, AND THEN FIRE IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257314 ↗
• MalfunctionDec 4, 2025Material Discolored; Self-Activation or Keying; Naturally Worn; Material Discolored; Self-Activation or Keying; Naturally Worn

  A PATIENT WAS PREPPED FOR THE BIOPSY PROCEDURE USING THE MAGNUM. PRIOR TO THE PROCEDURE, THE MAGNUM GUN FIRES ON ITS OWN. NO COAXIAL NEEDLE WAS USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723891 ↗
• MalfunctionNov 10, 2025Crack; Failure to Prime; Self-Activation or Keying; Crack; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT THE MAGNUM DRIVER FIRES BY ITSELF AFTER COCKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507976 ↗
• MalfunctionSep 18, 2025Material Discolored; Device Difficult to Setup or Prepare; Self-Activation or Keying; Component Missing; Material Twisted/Bent; Naturally Worn; Material Discolored; Device Difficult to Setup or Prepare; Self-Activation or Keying; Component Missing; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE MAGNUM DRIVER IS FIRING ON ITS OWN. IT WAS FURTHER REPORTED THAT THE DRIVER IS ABLE TO FULLY PRIME BUT FIRED ON ITS OWN WITHOUT PRESSING THE TRIGGER AFTER FIRST TIME COCKING. THE DEVICE WAS FIRED IMMEDIATELY AS THE USER RELEASED THE FINGER FROM THE COCKING SLIDE. THE SAFETY LEVER WAS IN "F" POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081113 ↗
• MalfunctionSep 16, 2025Self-Activation or Keying; Naturally Worn; Self-Activation or Keying; Naturally Worn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATE BIOPSY USING MAGNUM DEVICE. AND PRIOR TO THE PROCEDURE THE MAGNUM DEVICE SOMETIMES DOES NOT LOCK IN PRIMING POSITION, AND FIRE BY ITSELF. THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS JAMMING DURING THE PRIMING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060595 ↗
• MalfunctionJul 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Markings/Labelling Problem; Naturally Worn; Incorrect, Inadequate or Imprecise Result or Readings; Device Markings/Labelling Problem; Naturally Worn

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM AND IT WAS REPORTED THAT THE DEVICE WAS JAMMED AND WONT FIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402469 ↗
• MalfunctionJul 3, 2025Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT THE MAGNUM DEVICE FIRES WHEN IN FIRST CHARGE AND IT FIRES WELL BUT THE SECOND ONE FIRES BY ITSELF. THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED, THE DEVICE PRIMED AND LOCKED INTO THE FIRST PRIME POSITION THEN WHEN THEY WERE PRIMING THE SECOND TIME THE DEVICE PRIMED AND LOCKED INTO FULL PRIME POSITION THEN FIRED IMMEDIATELY AFTER IT WAS FULLY PRIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392168 ↗
• MalfunctionApr 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MAGNUM DEVICE THAT THE SERVICE CENTER RECEIVED HAD AN ADDITIONAL "L" AT THE BEGINNING OF THE SERIAL NUMBER. PER FURTHER DISCUSSION WITH ENGINEERING TEAM, AFTER THEIR RESEARCH ON THIS SERIAL NUMBER, DUE TO THE SERIAL NUMBER NOT MATCHING ON THE DEVICE BOX USED TO HOUSE THE MAGNUM DEVICE, THIS WILL BE TREATED AS A LABELING DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932678 ↗
• MalfunctionApr 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Self-Activation or Keying; Naturally Worn; Incorrect, Inadequate or Imprecise Result or Readings; Self-Activation or Keying; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE TRIGGERS WHEN WOUND UP. ADDITIONAL INFORMATION RECEIVED THAT A BARD NEEDLE INSTALLED WHEN THE MAGNUM DEVICE FIRED ON ITS OWN PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880341 ↗
• MalfunctionDec 27, 2024Break; Self-Activation or Keying; Break; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PRIME INDICATOR WAS ALLEGEDLY DETACHED, AND THE NEEDLE WAS PLACED IN THE GUN, AND IT ALLEGEDLY FIRED ON ITS OWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024777 ↗
• MalfunctionDec 6, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY LOCKED INTO THE SECOND PRIMING POSITION AND FIRED ON ITS OWN DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861473 ↗
• MalfunctionNov 19, 2024Break; Self-Activation or Keying; Material Twisted/Bent; Break; Self-Activation or Keying; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED WITHOUT PRESSING THE TRIGGER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730541 ↗
• MalfunctionNov 6, 2024Self-Activation or Keying; Device Contamination with Chemical or Other Material; Self-Activation or Keying; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED WITHOUT PRESSING THE TRIGGER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617777 ↗
• MalfunctionOct 18, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE CUSTOMER, THE DEVICE PRODUCES A BAD QUALITY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484528 ↗
• MalfunctionOct 3, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION OF A PROSTATE BIOPSY PROCEDURE, THE GUN ALLEGEDLY FIRES AUTOMATICALLY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357836 ↗
• MalfunctionOct 2, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE MOMENT CUSTOMER INSERTED THE NEEDLE, IT ALLEGEDLY FIRED BY ITSELF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350076 ↗
• MalfunctionOct 1, 2024Self-Activation or Keying; Naturally Worn; Self-Activation or Keying; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY UNABLE TO LOCK WHEN THE NEEDLE WAS INSERTED AND HAD FIRED OFF WITHOUT INTENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342661 ↗
• MalfunctionSep 7, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED BY ITSELF OUTSIDE A PATIENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164867 ↗
• MalfunctionJul 12, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY LOCKING AND FIRING ON THEIR OWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731972 ↗
• MalfunctionJul 12, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE DEVICE IS LOCKING AND FIRING ON THEIR OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731811 ↗