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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- PleurX 50-7500BCarefusion 2200, Inc · Apparatus, Suction, Patient Care66 reports
- Aspira® 00884450394946Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394915Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394861Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall1 report
- Aspira Dressing Kit 4991503Bard Access Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394984Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450398173Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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