N/A 50-7235ARecalls & reported problems
Carefusion 2200, Inc · Valve Cap, For use with the PleurX or PeritX Catheter Systems · Class 2 · Implant
- 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 10885403502378), received between Nov 5, 2025 and Nov 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging1
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.
MalfunctionNov 5, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING THE INSPECTION OF IMPORTS, ONE PACKAGING WAS FOUND WITH THE PRODUCT INSIDE BUT WITH THE PACKAGING OPEN AND WITH NO INDICATION THAT IT HAD EVER BEEN SEALED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE ISSUE WAS IDENTIFIED UPON RECEIVING THE PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479825 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.