MAGNUM MN1616Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741084300), received between Oct 19, 2016 and Dec 18, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING THE MAGNUM INSTRUMENT. DURING THE PROCEDURE, THE HANDLE OF THE FULLY AUTOMATED BIOPSY NEEDLE BROKE DURING THE PUNCTURE PROCESS, PREVENTING THE REMOVAL OF THE TISSUE SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835650 ↗
• MalfunctionSep 24, 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, IT WAS NOTED THAT THE DEVICE ALLEGEDLY HAD FOREIGN BODY IN THE SEALED PART. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23131409 ↗
• MalfunctionSep 23, 2025Break; Break

  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 23120236 ↗
• MalfunctionSep 23, 2025Break; Break

  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 23120234 ↗
• MalfunctionSep 23, 2025Break; Break

  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 23120233 ↗
• MalfunctionNov 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE TIP OF THE NEEDLE ALLEGEDLY HAD A FOREIGN BODY. NO COAXIAL NEEDLE WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793876 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED RENAL BIOPSY, THE BIOPSY NEEDLE WAS ALLEGEDLY SNAPPED ON THE BUTTERFLY WING PORTION OF THE BIOPSY GUN AND BROKEN. REPORTEDLY, THE NEEDLE WAS LEFT INSIDE THE BODY. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365909 ↗
• MalfunctionSep 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED HYPOECHOIC NODULE PUNCTURE OF THE BREAST BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY MALFUNCTIONING AND COULD NOT BE TAKEN NORMALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166312 ↗
• MalfunctionFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC RADICAL PROSTATECTOMY UNDER GENERAL ANESTHESIA ON (B)(6) 2023 AND BROUGHT BACK A URINARY CATHETER WITH PALE RED URINE. ON (B)(6) 2023, THE PATIENT DESCRIBED MILD SWELLING AND PAIN IN THE URETHRAL OPENING, WHICH AFFECTED COMFORT. THE EVENT CAUSE ANALYSIS AND DESCRIPTION STATED THAT THE PATIENT WAS NERVOUS AND WAS PROVIDED PSYCHOLOGICAL COUNSELLING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 18778367 ↗
• MalfunctionFeb 26, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL HOLMIUM LASER PROSTATE RESECTION, AND AFTER THE OPERATION, A THREE-LUMEN URETHRAL CATHETER WAS INSERTED TO FLUSH THE BLADDER TO STOP BLEEDING. BEFORE INSERTION, THE WATER INLET END OF THE URETHRA WAS TESTED TO BE UNOBSTRUCTED, AND THE BLADDER FLUSHING EFFECT COULD NOT BE ACHIEVED. A NEW THREE-LUMEN URINARY CATHETER WAS INSERTED AND THERE WERE NO ADVERSE EFFECTS ON PATIENTS. THE INSTRUMENT FAILURE SYMPTOMS STATED THAT THE WATER INLET END WAS BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777926 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST A PROSTATE BIOPSY PROCEDURE, THE BIOPSY NEEDLE'S BAYONET WAS ALLEGEDLY LOOSE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING WHICH WAS FIXED MANUALLY AND USED WITHOUT ANY OTHER TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381665 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PAIN AT THE PUNCTURE INCISION. REPORTEDLY THE PAIN WAS RELIEVED BY ANTI-INFLAMMATORY AND ANALGESIC DRUGS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 18225576 ↗
• InjuryJun 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE BEVEL OF THE NEEDLE ALLEGEDLY BROKE AT THE TIME OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166245 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT DURING A RENAL BIOPSY PROCEDURE, THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371073 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT DURING A RENAL BIOPSY PROCEDURE, THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370828 ↗
• MalfunctionJul 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MN1616 BIOPSY INSTRUMENT EXPERIENCED NEEDLE RUST. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE 68 YEAR OLD FEMALE PATIENT WAS 53 KGS.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10280207 ↗
• MalfunctionOct 19, 2016Device Markings/Labelling Problem; Device Markings/Labelling Problem; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ULTRA-SOUND GUIDED RENAL BIOPSY, THE BIOPSY NEEDLE WAS ALLEGEDLY IDENTIFIED TO BE A DIFFERENT SIZE THAN WHAT THE LABEL INDICATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6042608 ↗