MAGNUM MN1816Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741084348), received between Aug 11, 2021 and Nov 7, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING. IT WAS FURTHER REPORTED THAT A GELATIN SPONGE PARTICLE WAS USED TO EMBOLIZE THE TARGET BLOOD VESSEL TO CAUSE SLOW BLOOD FLOW IN THE PROXIMAL REGION. FURTHERMORE, A SPRING COIL WAS USED TO EMBOLIZE THE MAIN BLOOD VESSEL. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20629032 ↗
• MalfunctionMar 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE PACKAGING WAS ALLEGEDLY FOUND TO BE CONTAMINATED. A 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 18957636 ↗
• MalfunctionNov 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED SUPRACLAVICULAR LYMPH NODE BIOPSY, THE BIOPSY NEEDLE WAS ALLEGEDLY CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18199123 ↗
• MalfunctionOct 9, 2023Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED SUB FRONTAL LYMPH NODE PUNCTURE BIOPSY PROCEDURE, THE PUNCTURE NEEDLE WAS ALLEGEDLY CONTAMINATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17893658 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY SHOWED A SMALL AMOUNT OF BLEEDING AROUND THE LESION AND MILD HEMOTHORAX, IN THE POST OPERATIVE RE-SCAN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemothorax

  MAUDE report 17831757 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A CT-GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PLASTIC BUCKLE OF THE NEEDLE ALLEGEDLY BROKE. A COAXIAL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305721 ↗