PeritX 50-9900CRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885403501838), received between Feb 8, 2023 and Apr 2, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 ↗
• 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 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PERITX CATHETERS 50-9900C (PERITX PRODUCT) ARE BEING PACKAGED INSIDE PLEURX PACKAGING. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229892 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PERITX PLACEMENT KIT (ITEM # 50-9900C) IS BEING RECEIVED WITH OUTER PACKAGING LABELED AS THE PLEURX PLACEMENT KIT (ITEM # 50-7700). DUE TO THIS, THE CUSTOMER DOES NOT FEEL COMFORTABLE USING THE CATHETER. THERE WERE NO PATIENTS IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229808 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT PLEURX OUTER SHELL PACKAGING CONTAINED THE PERITX CATHETER AND TRAY INSIDE 50-9900C. THIS ISSUE OCCURRED WITH FIVE UNITS OF TRAY 50-9900C. THERE WAS NO PATIENT INVOLVEMENT, AND THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229717 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER RECEIVED SEVERAL PERITX KITS 50-9900C THAT WERE INCORRECTLY SHIPPED IN PLEURX-LABELED BOXES.

  Patient problems: Insufficient Information

  MAUDE report 23229585 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PERITX CATHETERS 50-9900C (PERITX PRODUCT) ARE BEING PACKAGED INSIDE PLEURX PACKAGING. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229521 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED BY CUSTOMER THAT THE PERITX CATHETERS 50-9900C (PERITX PRODUCT) ARE BEING PACKAGED INSIDE PLEURX PACKAGING. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229515 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM 50-9900C (PERITX PRODUCT) BUT RECEIVED THREE UNITS PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23228226 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM 50-9900C (PERITX PRODUCT), BUT RECEIVED ONE UNIT PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23219102 ↗
• MalfunctionOct 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PERITX 50-9900C WAS OPENED FOR A PROCEDURE AND WAS MISSING THE TUNNELLER, STIFFENER, AND PEEL-AWAY INTRODUCER. THE PROCEDURE HAD ALREADY BEGUN BEFORE STAFF REALIZED THESE COMPONENTS WERE MISSING. THE PACKAGING DOES NOT HAVE THESE ITEMS LISTED ON THE LABEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23219099 ↗
• MalfunctionOct 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PERITX CATHETERS 50-9900C (PERITX PRODUCT) ARE BEING PACKAGED INSIDE PLEURX PACKAGING.

  Patient problems: Insufficient Information

  MAUDE report 23219098 ↗
• MalfunctionFeb 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT SHEATH TORE OFF WHEN IT WAS REMOVED FROM THE WIRE. VERBATIM: I JUST WANTED TO REACH OUT AND LET YOU KNOW THAT WE HAD AN ISSUE WITH THE PERITX KIT SHEATH THAT WE HAVEN'T EXPERIENCE BEFORE. THE NEEDLE/SHEATH THAT IS USED TO GET ACCESS AND PASS THE WIRE TORE OFF WHEN IT WAS REMOVED FROM THE WIRE SO WE COULD PLACE THE DILATORS. ADDITIONAL INFORMATION RECEIVED 10-FEB-2023. THE DATE OF THE EXAM WAS (B)(6) 2023. THE NEEDLE ITSELF WAS NOT BROKEN BUT THE SHEATH THAT COVERS THE NEEDLE THAT IS USED TO PASS THE JWIRE WAS INTACT WHEN THE CASE STARTED BUT IT BROKE WHEN IT WAS REMOVED FROM THE WIRE. THE ISSUE HAPPENED DURING THE EXAM IT WAS USED ON THE PATIENT, WE TRIED TO REMOVE THE PIECE OF THE SHEATH BUT WE WERE UNABLE TO LOCATE IT. IT WAS LOCATED IN THE RIGHT SIDE OF THE ABDOMEN I DO HAVE A PHOTO OF THE BROKEN SHEATH BUT I DO NOT HAVE IT TO SEND BACK FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16378837 ↗
• InjuryFeb 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT THE CONNECTION TO DRAIN AND ALSO THE CAP DID NOT FIT PROPERLY TO THE INSERTED TUNNELED CATHETER. VERBATIM: AFTER INSERTION OF PERITX PERITONEAL CATHETER THE CONNECTION TO DRAIN AND ALSO THE CAP DID NOT FIT PROPERLY TO THE INSERTED TUNNELED CATHETER. A NEW KIT NEEDED TO BE OPENED AND REINSERTED. THERE WERE TWO OTHER CATHETERS WITH THE SAME LOT NUMBER 000147154 THAT WAS DIFFICULT TO FIT ON. (B)(6) 2023: THERE WAS NO DAMAGE NOTED ON THE CATHETER VALVE INITIALLY. THE TIP OF THE CATHETER THAT LOCKS INTO THE CAP OR THE DRAINAGE CONNECTER APPEARED TO BE MALFORMED OR BENT. IT WOULD NOT LOCK IN TO EITHER THE DRAINAGE CONNECTOR OR THE CAP. THE ADAPTER DID NOT APPEAR TO BE BROKEN. THE CAP ALSO DID NOT APPEAR BROKEN. NEITHER OF THESE WOULD LOCK INTO THE CATHETER. I'M NOT SURE WHAT IS MEANT BY WAS THERE A LEAKAGE. THIS OCCURRED DURING CATHETER INSERTION. THE CATHETER HAD JUST BEEN INSERTED WHEN IT WAS NOTICED. THE ENTIRE PROCEDURE WAS COMPLETED BUT WHEN I, A TECHNOLOGIST AND AN ATTENDING PHYSICIAN TRIED TO CONNECT THE CATHETER TO THE DRAINAGE ADAPTER IT WOULD NOT LOCK IN. WE TRIED MULTIPLE TIMES. WE ALSO TRIED BENDING THE LOCKING MECHANISM INTO A STRAIGHTER

  Patient problems: Insufficient Information

  MAUDE report 16325968 ↗