PleurX 50-9900Recalls & reported problems
Carefusion 2200, Inc · PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home Use · 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 10885403231537), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
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.
MalfunctionMar 15, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT EXPIRED PRODUCT. QUESTION: REP CALLED AND STATED SHE RECEIVED A CALL FROM /OMIT/ AT (B)(6) ABOUT A PHYSICIAN PLACING AN EXPIRED PLEURX. THE PRODUCT EXPIRED ON 12/31/2021 BUT SHE HAS NO OTHER INFORMATION FROM THE CUSTOMER. RESPONSE: EXPLAINED THE CASE NEEDED TO BE REPORTED TO FIELD ASSURANCE. BARD/BD CANNOT RECOMMEND PLACING ANY PRODUCT PAST THE LABELED EXPIRATION DATE. WE HAVE NO SPECIFIC INFORMATION OR TESTING ON USE OF AN EXPIRED PRODUCTS. WE CONSIDER THE KIT CONTENTS TO BE STERILE AS LONG AS THE PACKAGING IS INTACT WITH NO SIGNS OF DAMAGE. THE PHYSICIAN WILL HAVE TO DETERMINE RISK VS BENEFITS OF LEAVING THE PRODUCT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13772881 ↗
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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