PleurX 50-7050Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10885403075988), received between Nov 10, 2020 and Sep 30, 2026 — classified as 31 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Break” (50 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, 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

Recent adverse event reports

The 25 most recent of 137 reports, 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 ↗
• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354323 ↗
• 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 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 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT ON (B)(6) 2025, PLEURX PLEURAL CATHETER MINI KIT VALVE WAS CRACKED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE. NO MEDICAL INTERVENTION WAS REPORTED. NO EXPOSURE TO BLOOD / BODILY FLUID. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970411 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT VALVE WAS DAMAGED. IT WAS STATED THAT THE SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE, AND DRAINAGE WAS SUCCESSFUL. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970060 ↗
• MalfunctionJan 5, 2026Contamination

  IT WAS REPORTED THAT ON (B)(6) 2025, UPON OPENING THE PLEURX PLEURAL CATHETER MINI KIT PACKAGING, PRIOR TO INSERTION, A SMALL STRAND OF HAIR WAS FOUND INSIDE. THIS OCCURRED PRIOR TO INSERTION IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969352 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT ON NOVEMBER(B)(6) 2025, DURING USE OF THE PLEURX PLEURAL CATHETER MINI KIT, THE VALVE COMPONENT BROKE OFF. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE, AND THE PATIENT WAS DRAINED SUCCESSFULLY. THERE WAS NO EXPOSURE TO BLOOD/BODILY FLUID. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888474 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT PLEURX PLEURAL VALVE IS 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. THE CATHETER HAD BEEN IN PLACE SINCE (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790232 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE PLEURX PLEURAL CATHETER VALVE BROKEN OFF. 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. THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE DRAINAGE. THE CATHETER HAD BEEN IN PLACE SINCE (B)(6) 2020. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE VALVE IS NOT MANUFACTURED BY OUR ORGANIZATION. AS A RESULT, THE COMPLAINT IS NOT APPLICABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789943 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT ON OCTOBER 16, 2025, THE PLEURX PLEURAL CATHETER MINI KIT VALVE WAS LEAKING, SO A FLUSHING HOSE WAS CONNECTED TO ENSURE PROPER RELIEF. THE LEAKING VALVE WAS DRIPPING WITHOUT THE FLUSHING HOSE. THE DEVICE WAS SECURED WITH A CLAMP, AND THE FLUSHING HOSE WAS REMOVED, THEN THE VALVE WAS REPLACED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. IT WAS ALSO MENTIONED THAT SAFETY VALVE BROKEN/DAMAGED/DISCONNECTED. NO ADDITIONAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663064 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT VALVE WAS LEAKING, AND THE SAFETY VALVE WAS BROKEN/DAMAGED/DISCONNECTED. IT WAS ALSO REPORTED THAT THERE WERE AIR BUBBLES AFTER CONNECTING THE ACCESS TIP. THE VALVE WAS CHANGED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. NO ADDITIONAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663062 ↗
• InjuryNov 21, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, AFTER INSERTION OF THE PLEURX PLEURAL CATHETER KIT, THE VALVE IMMEDIATELY STARTED LEAKING. THE LINE WAS NOT CONNECTED, AND SINCE IT IS A ONE-WAY VALVE, NO LEAKAGE WAS EXPECTED. WHEN THE CAP WAS ATTACHED, FLUID CONTINUED TO DRIP, SOAKING THE PATIENT¿S TOP. THE LEAKAGE COULD NOT BE STOPPED, AND A STOPPER WITH TAPE HAD TO BE APPLIED TO ALLOW DRAINAGE. THE UNIT APPEARED TO BE FAULTY. DURING THE FOLLOW-UP RESPONSE IT WAS FURTHER REPORTED THAT THE CATHETER WAS LOCATED IN THE ABDOMEN. THE DAMAGE TO THE VALVE WAS NOTICED AFTER THE DRAIN WAS INSERTED AND THE PATIENT HAD STARTED DRAINING. THERE WERE NO SIGNS OF CRACKS ON THE VALVE, POSSIBLY BROKEN FROM THE INSIDE BECAUSE IT LEAKED, FLUID WAS COMING OUT DIRECTLY FROM THE VALVE, THIS HAPPENING WITHOUT THE DRAINAGE LINE AND THE BAG CONNECTED. ONCE CAP WAS CONNECTED, A FEW SECONDS LATER THE FLUID WOULD START DRIPPING. THE ISSUE WAS RESOLVED BY REPLACING THE FAULTY UNIT, PATIENT DUE FOR ANOTHER INSERTION WHILE THE DOCTOR TEMPORARILY TAPED THE CATHETER WITH A STOPPER TO ALLOW FLUID DRAINAGE UNTIL THE NEW INSERTION. BY THE TIME THE CATHETER WAS REMOVED, IT HAD BEEN IN PLACE FOR 14 DAYS, AS REMOVAL WAS DELAYED BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622591 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT THE VALVE OF THE PLEURX¿ PLEURAL CATHETER WAS 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. THE CATHETER HAD BEEN IN PLACE SINCE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550236 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A DAMAGED VALVE WAS IDENTIFIED DURING USE OF THE PLEURX PLEURAL CATHETER, RESULTING IN FLUID LEAKAGE. 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. THE CATHETER HAD BEEN IN PLACE SINCE (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550077 ↗
• InjuryOct 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PLEURX¿ PLEURAL CATHETER TUBE LEAKING DIRECTLY BEHIND THE VALVE. NO PATIENT INJURY WAS REPORTED. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT A HOLE WAS FOUND IN THE TUBE BEHIND THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405228 ↗
• InjuryOct 24, 2025Migration; Migration

  IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT AS THE CUFF WAS APPROXIMATELY 75 PERCENT EXPOSED FROM THE INSERTION SITE. IT WAS FURTHER REPORTED THAT THE PLEURX PRODUCT WAS DUE TO BE REMOVED IN OCTOBER SINCE IT HAD BEEN ALMOST A YEAR SINCE ITS INSERTION. PATIENT STATUS AFTER DEVICE REMOVAL IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 23385990 ↗
• MalfunctionOct 23, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A HOLE IN THE PLEURX TUBE BEHIND THE VALVE WAS CAUSED BY THE PATIENT WHILE USING A SHARP OBJECT. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE AND DRAINAGE WAS SUCCESSFUL. THE PATIENT WAS NOT EXPOSURE TO BLOOD/BODILY FLUID AND THERE WAS NO MEDICAL INTERVENTION. NO HARM TO THE PATIENT WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE HOLE WAS BEHIND THE VALVE, THE HOSE WAS CUT OFF WITH THE VALVE, AND A NEW VALVE WAS FITTED. THE TUBE WAS CUT TO REMOVE THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373533 ↗
• MalfunctionOct 15, 2025Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2025, THE VALVE OF A PLEURX¿ PLEURAL CATHETER WAS FOUND TO HAVE A CRACK. THERE WAS NO INJURY, OR IMPACT ON THE PATIENT, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306245 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING USE OF THE PLEURX PLEURAL CATHETER MINI KIT, THE SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAK. ALTHOUGH DRAINAGE WAS SUCCESSFUL, THE VALVE LEAKED WHEN THE DRAINAGE BAG WAS DISCONNECTED. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. THERE WAS NO REPORTED PATIENT INJURY OR EXPOSURE TO BODILY FLUIDS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303804 ↗
• MalfunctionSep 26, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING APPLICATION ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS NOT EXPOSURE TO BLOOD / BODILY FLUID. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE VALVE DID NOT DISCONNECT, BUT IT CRACKED AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155119 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL (BDPI-20-004 (ARCH)) OF A NON-COMMERCIALLY AVAILABLE DEVICE (BD LIVERTY TIPS STENT GRAFT STUDY), THAT A SUBJECT EXPERIENCED AN ADVERSE EVENT FOLLOWING THE USE OF A COMMERCIALLY AVAILABLE PLEURX CATHETER, WHICH WAS NOT PART OF THE STUDY. THE PLEURX CATHETER WAS IMPLANTED ON (B)(6) 2025. THE CATHETER WAS LOCATED IN THE LEFT LOWER ABDOMEN. ON DAY 3 POST-IMPLANTATION ((B)(6)2025), THE SUBJECT DEVELOPED SIGNS OF INFECTION, INCLUDING SEVERE LOWER ABDOMINAL PAIN, INCREASED ABDOMINAL GIRTH, AND WATER RETENTION IN THE LEGS AND SCROTUM. THE CATHETER WAS EXPLANTED ON (B)(6) 2025. THE SEVERITY OF THE ADVERSE EVENT WAS MILD. THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED/RECOVERED FOLLOWING IMPLANTATION OF A NEW PLEURX CATHETER ON (B)(6) 2025. NO PHOTOS WERE AVAILABLE FOR REVIEW.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23017418 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING USE OF THE PLEURX PLEURAL CATHETER MINI KIT, THE SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE VALVE WAS CHANGED, AND ISSUE WAS RESOLVED. THERE WAS NO MEDICAL INTERVENTION AND THERE WAS NO EXPOSURE TO BLOOD / BODILY FLUID. DRAINAGE WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY. DURING FOLLOW UP RESPONSE IT WAS CONFIRMED THE VALVE WAS LEAKING. THE VALVE DID NOT DISCONNECT ON THE CATHETER. THE DEVICE WAS PLACED IN THE PLEURA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947894 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. THE PATIENT WAS SUCCESSFULLY DRAINED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946258 ↗