Aspira Drainage Tray 4992507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741091152), received between Dec 6, 2017 and Jan 30, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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.

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.

• MalfunctionJan 30, 2018Material Separation

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ASPIRA CATHETER WHERE THE INGROWTH CUFF SEPARATED FROM THE CATHETER DURING PLACEMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229740 ↗
• MalfunctionDec 6, 2017Detachment Of Device Component

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED THAT THE CUFF OF THE ASPIRA BECAME DETACHED DURING TUNNELING.

  Patient problems: No Information

  MAUDE report 7087988 ↗