PleurX 50-9000BRecalls & reported problems
Carefusion 2200, Inc · PleurX Peritoneal Catheter Kit, For Peritoneal Placement, 15.5 Fr · Class 2 · Implant
All models of PleurX (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403075957), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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 16, 2026.
Most reported problems
Device problems
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2021Contamination; Contamination
IT WAS REPORTED THAT: THERE WAS A YELLOWISH SUBSTANCE. VERBATIM: IN SPECIAL PROCEDURES: ITEM NUMBER 50-9000B-PENTONEAL PLEURX CATHETER KIT (CAREFUSION) WAS OPENED TO PREP FOR PLEURX PLACEMENT PROCEDURE. WHEN PRODUCT WAS OPENED, THERE WAS A YELLOWISH SUBSTANCE ON THE END OF THE CONNECTING TUBE THAT CONNECTS TO THE PLEURX CATHETER. THIS KIT WAS REMOVED FROM THE STERILE FIELD AND STERILE FIELD WAS RE-PREPPED AND A NEW PLEURX KIT WAS OPENED. THE SAME YELLOWISH SUBSTANCE WAS IN THE SAME PLACE, BUT ON A NEWLY OPENED PACKAGE. THIS PRODUCT WAS ALSO DISCARDED. A THIRD ITEM WAS OPENED ON A STERILE ENVIRONMENT THAT WAS SET UP AWAY FROM THE LARGE STERILE TRAY. THIS PLEURX KIT DID NOT HAVE THE YELLOWISH SUBSTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12983874 ↗
Other Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling devices
- PleurX 50-7510Carefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 deaths126 reports
- Aspira® 00884450398166Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 recalls0 reports
- Aspira® 00884450394908Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall2 reports
- Aspira® 00884450394892Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall0 reports
- PeritX 50-9050ACarefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling38 reports
- Aspira® 00884450394878Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling29 reports
- PeritX 50-9900CCarefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling15 reports
- PleurX 50-9050Carefusion 2200, Inc · Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling7 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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