MAGNUM MN1416Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741084263), received between May 6, 2022 and Mar 18, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING MAGNUM DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE WAS ALLEGEDLY BREAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629083 ↗
• MalfunctionMar 18, 2026Break

  A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING MAGNUM DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE WAS ALLEGEDLY BREAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625388 ↗
• MalfunctionMar 5, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM NEEDLE. DURING THE PROCEDURE, THE CONNECTION POINT AT THE ASPIRATION INTERFACE OF THE DISPOSABLE BIOPSY NEEDLE RUPTURED WHEN A 20 ML SYRINGE WAS ATTACHED. FURTHER IT WAS REPORTED THAT THIS PREVENTED THE FORMATION OF NEGATIVE PRESSURE AND RENDERED THE DEVICE INCAPABLE OF ASPIRATING SUBCUTANEOUS TISSUE ABSCESSES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516754 ↗
• MalfunctionMar 5, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT BIOPSY PROCEDURE USING MAGNUM NEEDLE. DURING THE PROCEDURE, THE SUCTION PORT OF THE DISPOSABLE BIOPSY NEEDLE RUPTURED. FURTHER IT WAS REPORTED THAT PREVENTING THE GENERATION OF NEGATIVE PRESSURE AND RENDERING THE DEVICE INOPERABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516306 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING A MAGNUM. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289569 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING A MAGNUM. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289511 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING A MAGNUM. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289510 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING A MAGNUM. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289506 ↗
• MalfunctionJan 8, 2026Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING A MAGNUM NEEDLE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000792 ↗
• MalfunctionDec 26, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC BREAST BIOPSY PROCEDURE USING THE MAGNUM NEEDLE. DURING THE PROCEDURE, THE PLASTIC PART ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894826 ↗
• MalfunctionNov 19, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590575 ↗
• MalfunctionNov 19, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM. DURING THE PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590573 ↗
• MalfunctionNov 18, 2025Break; Break

  ON (B)(6) 2025, 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 23578544 ↗
• MalfunctionNov 18, 2025Break; Break

  ON (B)(6) 2025, 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 23578534 ↗
• MalfunctionMay 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE HAIR WAS ALLEGEDLY FOUND ON THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14302386 ↗