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Aspira Drainage Kit 4992508Recalls & reported problems

Bard Access Systems, Inc. · Aspira Pleural Drainage Kit · Class 2 · Implant

All models of Aspira Drainage Kit (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741091169), received between Oct 7, 2016 and Apr 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Cut In Material” (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

Device problems

  • Cut In Material1
  • Hole In Material1

Patient problems

  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 12, 2017Hole In Material

    FACILITY REPORTED TO THE SALES REP THAT THERE IS A HOLE IN THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6486055 ↗
  • MalfunctionOct 7, 2016Cut In Material

    A REPORTED BY THE FACILITY TO THE DISTRIBUTOR: "THE CATHETER LOOKS LIKE IT'S BEEN CUT WITH A KNIFE BECAUSE THERE'S A HUGE SLIT AT THE TOP OF THE TRAY."

    Patient problems: No Information

    MAUDE report 6010596 ↗

Other APPARATUS, SUCTION, PATIENT CARE devices

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Sources and updates

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