Aspira Drainage Tray 4992506Recalls & reported problems
Bard Access Systems, Inc. · Aspira Pleural Drainage Insertion Tray · Class 2 · Implant
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 00801741045073), received between Aug 2, 2017 and Aug 18, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).
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
- Improper or Incorrect Procedure or Method2
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2017Improper or Incorrect Procedure or Method; Material Integrity Problem
FACILITY REPORTED TO THE SALES REP THAT THE PHYSICIAN WAS IMPLANTING THE DEVICE AND CUT OFF THE Y-PORT AND LEFT THE STYLET INSIDE THE CATHETER. THE PHYSICIAN AND THE NURSE STATED THE STYLET AND THE CATHETER IS THE SAME COLOR, IF IT WERE A DIFFERENT COLOR, PHYSICIAN AND NURSE WOULD HAVE DETECTED THE SYTLET MORE EASILY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6804406 ↗MalfunctionAug 2, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DURING TUNNELED PLEURAL CATHETER INSERTION THE CATHETER WAS TRIMMED WITH THE STYLET STILL INSIDE THE CATHETER. THIS RESULTED IN AN UNINTENTIONAL RETAINED FOREIGN OBJECT. THE STYLET REMAINED IN THE CATHETER UNTIL IT WAS DISCOVERED AND REMOVED 72 HOURS LATER. THE STYLET IS CONNECTED TO THE CATHETER IN SUCH A MANNER THAT IT APPEARS TO BE A PART OF THE CATHETER. THE STYLET IS THE SAME COLOR AND MATERIAL AS THE CATHETER MAKING IT DIFFICULT TO SEE THAT IT IS PRESENT IN THE CATHETER. THE INSTRUCTIONS INCLUDED IN THE KIT DO NOT CLEARLY SHOW WHAT THE STYLET LOOKS LIKE IN THE DIAGRAMS AND CAN EASILY BE CONFUSED WITH A GUIDEWIRE. IF THE STYLET WAS MADE OF A DIFFERENT COLOR IT WOULD HAVE BEEN MORE APPARENT THAT IT HAD BEEN RETAINED.
Patient problems: Foreign Body In Patient
MAUDE report 6797873 ↗
Other APPARATUS, SUCTION, PATIENT CARE devices
- PleurX 50-7050Carefusion 2200, Inc · APPARATUS, SUCTION, PATIENT CARE137 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page