PleurXRecalls & reported problems across all models
Carefusion 2200, Inc · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 388
- Deaths reported
- 3
- Injuries reported
- 55
- Recalls
- 0
We found 14 models of PleurX by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 388 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2016 and Sep 30, 2026 — classified as 3 deaths, 55 injuries, 330 malfunctions.
The most frequently reported specific device problem is “Break” (67 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PleurX problems
Device problems
- Break67
- Fluid/Blood Leak41
- Detachment of Device or Device Component29
- Material Separation29
- Fracture28
- Sharp Edges25
- Leak/Splash23
- Material Puncture/Hole20
Patient problems
- No Clinical Signs, Symptoms or Conditions331
- No Consequences Or Impact To Patient33
- Pneumothorax8
- Foreign Body In Patient6
- Insufficient Information6
- Bacterial Infection4
- No Known Impact Or Consequence To Patient4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
PleurX models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PleurX 50-7050APPARATUS, SUCTION, PATIENT CARE137 reports
- PleurX 50-7510Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 deaths126 reports
- PleurX 50-7500BApparatus, Suction, Patient Care66 reports
- PleurX 50-7000BAPPARATUS, SUCTION, PATIENT CARE1 death25 reports
- PleurX 50-7700APPARATUS, SUCTION, PATIENT CARE8 reports
- PleurX 50-9050Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling7 reports
- PleurX 50-7245Apparatus, Suction, Patient Care5 reports
- PleurX 50-7210Apparatus, Suction, Patient Care4 reports
- PleurX 50-7280Apparatus, Suction, Patient Care4 reports
- PleurX 50-7270APPARATUS, SUCTION, PATIENT CARE2 reports
- PleurX 50-9000BPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling1 report
- PleurX 50-7265Apparatus, Suction, Patient Care1 report
- PleurX 50-7205BApparatus, Suction, Patient Care1 report
- PleurX 50-9900Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling1 report
Recent PleurX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951863 ↗MalfunctionSep 24, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876529 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354323 ↗MalfunctionJul 20, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881806 ↗MalfunctionJul 20, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881651 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2026, THE PLEURX LOCKABLE DRAINAGE LINE TUBING BECAME DISCONNECTED FROM THE LUER LOCK TO CONNECT TO THE CATHETER. A NEW TRAY WAS OPENED TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303211 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT THE VALVE OF THE PLEURX PLEURAL CATHETER WAS BROKEN OR DAMAGED, DISCONNECTED RESULTING IN LEAKAGE. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODY FLUIDS. NO PATIENT INJURY WAS REPORTED. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. THE CATHETER, POSITIONED IN THE PLEURA, HAD BEEN IN PLACE (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705752 ↗MalfunctionMar 20, 2026Unsealed Device Packaging
IT WAS REPORTED BY CUSTOMER THAT PLEURX DRAINAGE KIT MANUFACTURED BOX WAS OPENED NOT SEALED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE OUTER CARTON OR SHIPPING BOX WAS CUT OPENED. SEEMED LIKE AN ISSUE WITH THE CARRIER. THE INTERNAL BAG OR PACKAGE CONTAINING THE BOTTLE WAS ALSO CUT OPEN, AS IT HAD BEEN SLICED THROUGH. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24655928 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THAT THE PLEURX DRAINAGE KIT PLUNGER WAS DEFECTIVE. NO PATIENT HARM WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE DRAIN VALVE BROKE. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL FOLLOW UP RECEIVED BY THE CUSTOMER STATED THE PIECE CONNECTED TO THE CATHETER THAT IS INSERTED IN THE PATIENT'S LUNG IS THE COMPONENT THAT BROKE AND THAT THE BOTTLE PLUNGER WAS NOT BROKEN. THE CATHETER/TUBE WAS NOT REPLACED BUT WAS CUT, MADE SHORTER AND ADDED A REPLACEMENT VALVE. THE PATIENT WAS SUCCESSFULLY TREATED WITHOUT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24599380 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT THE VALVE OF THE PLEURX PLEURAL CATHETER WAS BROKEN AND DAMAGED. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODY FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24573232 ↗MalfunctionFeb 24, 2026Device Handling Problem
IT WAS REPORTED BY CUSTOMER THAT A TUBE DAMAGED BY SCISSORS, MANIPULATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434798 ↗MalfunctionFeb 24, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2026, THE DURING ROUTINE PLEURX DRAIN CARE, STAFF NOTICED A WET SPOT ON THE STERILE DRAPE. UPON INSPECTION, THEY FOUND THAT THE TUBING ATTACHED TO THE PLEURX BOTTLE WAS LEAKING FLUID ONTO THE STERILE FIELD. THE DRAINAGE PROCEDURE WAS STOPPED, THE LEAKING BOTTLE WAS DISCONNECTED, AND A NEW BOTTLE AVAILABLE IN THE HOME WAS ATTACHED. THE DEVICE INVOLVED WAS NOT IMPLANTED AND NOT RETAINED. NO PATIENT INJURY WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED BETWEEN THE DISTAL END OF THE ACCESS TIP AND THE ATTACHED DRAINAGE LINE. THERE WAS NO DAMAGE NOTED TO THE ACCESS TIP OR THE PATIENT'S VALVE. THE PATIENT'S CATHETER IS AN ABDOMINAL PLEURX ON THEIR RIGHT SIDE. DUE TO THE LEAKAGE, BODILY FLUID LEAKED ON TO PATIENT'S LAP, SATURATING A SMALL PORTION OF THEIR PANTS AND ON TO THEIR CHAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434796 ↗MalfunctionJan 26, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185418 ↗MalfunctionJan 26, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185155 ↗MalfunctionJan 26, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185154 ↗
Other Carefusion 2200, Inc products
All Carefusion 2200, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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