PeritXRecalls & reported problems across all models

We found 5 models of PeritX by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2022 and Jul 10, 2026 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (21 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

Most reported PeritX problems

PeritX models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PeritX 50-9050A

  Peritoneal, drainage catheter for refractory ascites, long-term indwelling
  38 reports
• PeritX 50-9900C

  Peritoneal, drainage catheter for refractory ascites, long-term indwelling
  15 reports
• PeritX 50-9510

  Peritoneal, drainage catheter for refractory ascites, long-term indwelling
  3 reports
• PeritX 50-9210

  Peritoneal, drainage catheter for refractory ascites, long-term indwelling
  2 reports
• PeritX 50-9000C

  Peritoneal, drainage catheter for refractory ascites, long-term indwelling
  1 report

Recent PeritX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787644 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE VALVE WAS LEAKING DURING USE. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE, AFTER WHICH SUCCESSFUL DRAINAGE WAS ACHIEVED. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION REQUIRED, AND NO IMPACT ON THE PATIENT OR COURSE OF TREATMENT. THE SAFETY VALVE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS PERFORMED BY AN EWIMED EMPLOYEE AT THE PATIENT¿S HOME, WITH THE CATHETER PLACED IN THE ASCITES POSITION SINCE (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412809 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER ON MARCH 11, 2026, THAT THE PERITX DRAINAGE BAG WAS LEAKING DURING USE, DESPITE CONFIRMATION THAT BOTH THE DRAINAGE END AND THE CLAMP WERE SECURELY CLOSED. DURING FOLLOW UP INFORMATION RECEIVED ON MARCH 29, 2026, IT WAS FURTHER REPORTED THAT THERE WAS NO DIRECT PATIENT OR HEALTHCARE PROVIDER INJURY. THE SOURCE OF THE LEAK COULD NOT BE CLEARLY IDENTIFIED. THE REPORTER STATED THAT AFTER ENSURING THE DRAINAGE CAP WAS TWISTED CLOSED, APPROXIMATELY 1000 ML OF FLUID WAS COLLECTED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT, THE ROLLER CLAMP WAS CLOSED, AND THE PLEURX BAG WAS DISCARDED INTO A GARBAGE BAG PLACED ON THE FLOOR. SHORTLY THEREAFTER, AN ESTIMATED 500 ML OF FLUID LEAKED ONTO THE FLOOR. DUE TO THE VOLUME OF FLUID AROUND THE BAG, THE EXACT SOURCE OF THE LEAK COULD NOT BE VISUALLY DETERMINED. AS THE DRAINAGE CAP AND ROLLER CLAMP HAD BEEN CONFIRMED CLOSED, THE LEAK WAS SUSPECTED TO HAVE ORIGINATED FROM THE BAG ITSELF OR POSSIBLY FROM THE CONNECTION BETWEEN THE BAG AND THE TUBING. THE CUSTOMER STATED THAT THEY HAD HEARD OF SEVERAL OTHER INSTANCES OF BAGS LEAKING IN THE PAST MONTH. DURING FOLLOW UP, THE CUSTOMER INDICATED THEY WERE NOT AWARE OF ANY PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848768 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2026, THAT THE PERITX DRAINAGE BAG WAS LEAKING DURING USE, DESPITE CONFIRMATION THAT BOTH THE DRAINAGE END AND THE CLAMP WERE SECURELY CLOSED. DURING FOLLOW UP INFORMATION RECEIVED ON MARCH 29, 2026, IT WAS FURTHER REPORTED THAT THERE WAS NO DIRECT PATIENT OR HEALTHCARE PROVIDER INJURY. THE SOURCE OF THE LEAK COULD NOT BE CLEARLY IDENTIFIED. THE REPORTER STATED THAT AFTER ENSURING THE DRAINAGE CAP WAS TWISTED CLOSED, APPROXIMATELY 1000 ML OF FLUID WAS COLLECTED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT, THE ROLLER CLAMP WAS CLOSED, AND THE PLEURX BAG WAS DISCARDED INTO A GARBAGE BAG PLACED ON THE FLOOR. SHORTLY THEREAFTER, AN ESTIMATED 500 ML OF FLUID LEAKED ONTO THE FLOOR. DUE TO THE VOLUME OF FLUID AROUND THE BAG, THE EXACT SOURCE OF THE LEAK COULD NOT BE VISUALLY DETERMINED. AS THE DRAINAGE CAP AND ROLLER CLAMP HAD BEEN CONFIRMED CLOSED, THE LEAK WAS SUSPECTED TO HAVE ORIGINATED FROM THE BAG ITSELF OR POSSIBLY FROM THE CONNECTION BETWEEN THE BAG AND THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779862 ↗
• MalfunctionApr 2, 2026Wrong Label

  IT WAS REPORTED THAT THE PERITX ITEM CAME PACKAGED IN A PLEURX BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765533 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN SUBSTANCE WAS OBSERVED PROTRUDING FROM THE SITE OF THE PERITX ABDOMINAL DRAIN DEVICE. DURING FOLLOW UP IT WAS REPORTED THAT THE TREATING PHYSICIAN ELECTED TO MANAGE THE ISSUE WITH ORAL ANTIBIOTICS. THE CLINICIAN DECIDED TO LEAVE THE DRAIN IN SITU, AS THE PATIENT IS CURRENTLY RECEIVING END OF LIFE CARE AND THE PHYSICIAN DID NOT WANT TO SUBJECT THE PATIENT TO A REMOVAL AND REINSERTION PROCEDURE. THE DRAIN REMAINS IN SITU, AND THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 24631922 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THE VALVE OF THE PERITX PERITONEAL CATHETER WAS BROKEN OR DAMAGED, RESULTING IN LEAKAGE. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODILY FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. DESPITE THE LEAKAGE, DRAINAGE REMAINED SUCCESSFUL, WITH NO IMPACT ON THE PATIENT AND NO CHANGES TO THE COURSE OF TREATMENT. THE CATHETER, POSITIONED IN THE PLEURA, HAD BEEN IN PLACE SINCE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372398 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2025, A PATIENT CAME TO THE UGEI WITH INFLAMED SKIN ON THE PATHWAY LOOKING LIKE INFECTIOUS DERMOHYPODERMATITIS AND THE INTERVENTIONAL RADIOLOGY UNIT WAS CONCERNED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24084421 ↗
• MalfunctionJan 5, 2026Device Handling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PERITX PERITONEAL CATHETER MINI KIT VALVE WAS DAMAGED BY THE PATIENT. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO EXPOSURE TO BLOOD / BODILY FLUID WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970717 ↗
• 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 ↗
• MalfunctionDec 18, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WERE FOUR PERITX PERITONEAL CATHETER & STARTER KITS RECEIVED IN PLEURX PLEURAL CATHETER KIT BOXES AND WITHOUT STARTER KITS. DURING FOLLOW UP RESPONSE IT WAS REPORTED THAT THE ISSUE OCCURRED PRIOR TO USE, WHEN THE PRODUCT WAS RECEIVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840699 ↗
• MalfunctionDec 12, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED ON NOVEMBER 20, 2025, THAT DURING PERITX DRAIN PLACEMENT, THE CONDUCTOR BECAME STUCK INSIDE THE PEEL-AWAY CATHETER AND COULD NOT BE REMOVED AFTER MULTIPLE ATTEMPTS. THE PEEL-AWAY AND DILATOR WERE REMOVED, BUT THE CONDUCTOR REMAINED LODGED UNTIL FREED USING AN ADDITIONAL 4F CATHETER. THE CONDUCTOR WAS FOUND SPIRAL-SHAPED WITH SURFACE COATING ROLLED UP. A NEW PERITX SET WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXPOSURE TO BLOOD/BODILY FLUIDS OCCURRED. DRAINAGE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791149 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) , 2025, THE VALVE WAS REMOVED AS IT DETACHED (DOES NOT HOLD, SLIPPED OUT) AND SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS REPLACED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660382 ↗
• MalfunctionNov 7, 2025Wrong Label; Wrong Label

  IT WAS REPORTED BY CUSTOMER THAT THE PERITX TRAY CAME IN PLEURX BOX / OUTER PACKAGING. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING WAS CONFIRMED TO BE A PERITX CATHETER TRAY. THE ISSUE WAS IDENTIFIED PRIOR TO USE; THE PRODUCT WAS NOT USED ON A PATIENT. NO ADVERSE EVENTS, PROCEDURAL DELAYS, OR CLINICAL CONCERNS WERE REPORTED, ONLY INITIAL CONFUSION DUE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501577 ↗
• MalfunctionOct 29, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING USE OF THE PERITX PERITONEAL CATHETER MINI KIT, THE VALVE WAS DAMAGED BY OTHER UNKNOWN MATERIAL, AND THE SAFETY VALVE WAS FOUND BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE AND DRAINAGE WAS SUCCESSFUL. THERE WERE NO MEDICAL INTERVENTION AND THERE WAS NO EXPOSURE TO BLOOD/BODILY FLUID. NO IMPACT TO THE PATIENT WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT AN UNKNOWN MATERIAL WAS CONNECTED BY FORCE, BUT IT IS UNCLEAR WHAT MATERIAL COMPONENTS WERE CONNECTED BY FORCE. IT WAS CLARIFIED THAT THE VALVE WAS CRACKED BUT IT IS UNKNOWN IF THE VALVE DISCONNECTED. THE PATIENT IS BEING TREATED FOR ASCITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420412 ↗

Other Carefusion 2200, Inc products

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