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Aspira Drainage Tray 4992509Recalls & reported problems

Bard Access Systems, Inc. · Aspira Pleural Drainage Catheter 15.5F Insertion Tray · Class 2 · Implant

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741091176), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Detachment Of Device Component1

Patient problems

  • Cellulitis1
  • Fluid Discharge1
  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjurySep 20, 2017Break; Detachment Of Device Component

    IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD AN ASPIRA PLEURAL CATHETER PLACED BY PHYSICIAN #1, IN INTERVENTIONAL RADIOLOGY. IT WAS SUBSEQUENTLY REMOVED IN INTERVENTIONAL RADIOLOGY BY PHYSICIAN #2, ON (B)(6) 2016. PATIENT HAS HAD PERSISTENT DRAINAGE AND CHEST WALL CELLULITIS RESULTING IN CONSULTATION WITH INFECTIOUS DISEASE, PHYSICIAN RECOMMENDED ANTIBIOTIC THERAPY. PATIENT HAS HAD POOR HEALING AND TWO COURSES OF ANTIBIOTICS PRIOR TO SEEING THE INFECTIOUS DISEASE PHYSICIAN, SEVERAL CT SCANS WERE PERFORMED DURING THE COURSE OF CARE. PATIENT HAS REMAINED ON CHRONIC DOXYCYCLINE OVER THE COURSE OF THE YEAR. IN 2017 THE PATIENT IDENTIFIED A FIBRINOUS MATERIAL AT THE SITE. A FOREIGN BODY IN A CYLINDRICAL SHAPE WAS REMOVED FROM THE PATIENTS CHEST WALL BY PHYSICIAN #3, PRESUMED TO BE THE CUFF FROM THE CATHETER. PROVIDER FELT THAT HE HAD REMOVED THE CATHETER INTACT.

    Patient problems: Cellulitis; Fluid Discharge; Foreign Body In Patient

    MAUDE report 6880020 ↗

Other APPARATUS, SUCTION, PATIENT CARE devices

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Sources and updates

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