Aspira® 00884450394908Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450394908), received between Mar 21, 2023 and Mar 21, 2023 — 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-1911-2023 · 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.

• MalfunctionMar 21, 2023Fracture; Fracture

  THE CUSTOMER REPORTS THAT WHEN THEY HOOK UP THE ADAPTERS IN THE KIT, THE FLUID WOULD NOT DRAIN. PHYSICIAN USED THE REPAIR KIT TO FIX THE DRAIN ISSUE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587530 ↗
• MalfunctionMar 21, 2023Fracture; Fracture

  THE CUSTOMER REPORTS THAT WHEN THEY HOOK UP THE ADAPTERS IN THE KIT, THE FLUID WOULD NOT DRAIN. PHYSICIAN USED THE REPAIR KIT TO FIX THE DRAIN ISSUE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587527 ↗