Aspira® 00884450394915Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450394915), received between Oct 5, 2021 and Oct 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 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-1913-2023 · 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.

• MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE THE PHYSICIAN WAS TUNNELING THE CATHETER BEFORE USE WITHIN THE PROCEDURE, THE CUFF DETACHED FROM THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE. NO PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580002 ↗
• MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE REMOVAL OF AN ASPIRA DEVICE FROM THE PATIENT BY INTERVENTIONAL RADIOLOGY, THE CUFF OF THE CATHETER SEPARATED FROM THE REST OF THE DEVICE AND WAS RETAINED WITHIN THE PATIENT'S PLEURAL TISSUE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12580000 ↗