AXS Universal Aspiration Tubing 077.0193Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07612367052719), received between Jan 26, 2021 and Jan 26, 2021 — classified as 1 injury.

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

1 FDA recall record name this device's identifier.

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. Dec 2, 2020Class IITerminated

   Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

   Z-1502-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE ASPIRATION TUBING (SUBJECT DEVICE) FROM THE MICROCATHETER TO MANUALLY SYRINGE ASPIRATE. DURING THIS ATTEMPT, THE SUBJECT TUBING CONNECTOR GOT STUCK IN THE MICROCATHETER AND BROKE. ADDITIONAL DEVICE (TWEEZER) WAS USED AS A MEDICAL INTERVENTION TO REMOVE THE BROKEN PART OF TUBE CONNECTOR FROM THE PATIENT'S ANATOMY. DURING THE REMOVAL PROCESS, IT WAS REPORTED THAT THE PUMP WAS OFF AND THE CLAMP WAS CLOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228319 ↗