PeritX 50-9510Recalls & reported problems
Carefusion 2200, Inc · PeritX Drainage Kit, 2000 mL · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403222412), received between May 19, 2025 and Dec 18, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOUR PERITX BAGS WERE LEAKING AT THE SEALED GASKET. IT WAS ALSO MENTIONED THAT THE PACKS ARE LEAKING AT THE SEALED GASKET AND SPOUT CONNECTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842285 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NURSE WAS SPLASHED IN THE FACE AND EYES WITH THE PATIENT'S FLUID AND WAS TREATED ACCORDING TO THE OCCUPATIONAL HEALTH AND SAFETY (OHS) PROCESS. IT WAS FURTHER REPORTED THAT BLOOD WORK WAS DONE AS PART OF MEDICAL INTERVENTION; HOWEVER, BLOOD RESULTS ARE UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22049101 ↗MalfunctionMay 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE PERITX DRAINAGE BAG CAP SYSTEM HAD A LEAK, EVEN AFTER TIGHTENED THE DRAINAGE BAG CONTINUED TO LEAK. IT WAS FURTHER REPORTED THAT THE LEAK OCCURRED FROM THE BOTTOM DRAINAGE VALVE OF THE PERITX BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049098 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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