Aspira® 00884450394946Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450394946), received between Apr 18, 2023 and Sep 4, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 18, 2026.

Recalls naming this device

1. Apr 22, 2023Class IIOpen, Classified

   There is a potential that valve assemblies will not open. preventing fluid from draining.

   Z-1915-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING REMOVAL OF THE CATHETER, THE POLYESTER CUFF CAME OFF. THE REMOVAL REQUIRED OPENING THE AREA TO ALLOW FOR REMOVAL OF THE CUFF FOLLOWED BY STITCHING UP THE AREA. NO ADDITIONAL DETAILS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680500 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A TUNNELED PLEURAL DRAINAGE CATHETER PLACEMENT PROCEDURE, AIR WAS NOTED TO BE INFILTRATING THE SYSTEM. THE PHYSICIAN HAD PLACED A TUNNELED PLEURAL DRAINAGE CATHETER AND ATTEMPTED TO BEGIN DRAINING BUT THEY WERE EXPERIENCING AIR BACKFLOW. THEY TRIED REPOSITIONING THE CATHETER AND RECONNECTING IT, BUT IT WOULD STILL NOT DRAIN CORRECTLY. THE PHYSICIAN REMOVED THE CATHETER THINKING IT WAS MALFUNCTIONING, WHICH INADVERTENTLY CAUSED A PNEUMOTHORAX IN THE PATIENT. A CHEST TUBE WAS IMPLANTED TO TREAT THE PATIENT. THE PHYSICIAN PLACED ANOTHER TUNNELED PLEURAL DRAINAGE CATHETER ONLY TO REALIZE IT WAS THE VALVE CONNECTION THAT WAS MALFUNCTIONING, NOT THE CATHETER. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Pneumothorax

  MAUDE report 16763170 ↗