PleurX 50-7280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403185694), received between Dec 16, 2021 and Jan 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT WAS CLOGGED. QUESTION: CALLER STATES THEY ARE WORKING WITH A PATIENT IN THE ER WHO HAS A PLEURX PLEURAL CATHETER THAT IS CLOGGED. CALLER ASKING HOW TO FLUSH THIS CATHETER AND WHAT IS THE PRIMING VOLUME. CALLER ASKING IF IT IS OKAY TO USE CATHFLO TO HELP UNCLOG THE CATHETER. WHAT DOSE OF CATHFLO SHOULD THEY USE? SHOULD THIS BE DONE UNDER IMAGING? RESPONSE: PROVIDED 2.6ML TO THE FIRST FENESTRATION AND 4.2ML TO THE END IF THE CATHETER. EXPLAINED THAT CATHFLO CAN BE USED TO HELP UNCLOG THE CATHETER. BD DOES NOT PROVIDE DOSAGE RECOMMENDATION FOR CATHFLO. SUGGESTED THEY FOLLOW THE PACKAGE INSERT FOR CATHFLO. ND DOSES NOT HAVE RECOMMENDATION REGARDING IF IMAGING SHOULD BE USED. CONFIRMED THAT IMAGING WILL BE DEPENDENT ON INSTITUTION PROTOCOL. EMAILED CATALOG EXCERPT FOR THE PLEURX CATHETER KIT- PRODUCT CODE/ REFERENCE NUMBER: 50-7280. I WOULD CHECK WITH CENTERAL SUPPLY AND SEE IF YOU HAVE THIS PRODUCT CODE OR CHECK WITH A NEIGHBORING HOSPITAL WHO MIGHT HAVE THIS ITEM. USING ANY OTHER DEVICE TO ACCESS THE CATHETER COULD DAMAGE THE CATHETER VALVE. ON (B)(6) 2023: SUCCESSFUL DRAINAGE COMPLETED. NO PATIENT HARM THAT IS KNOW AT THIS TIME. LINE FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229419 ↗
• MalfunctionDec 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE ISSUES RE ACCESS TIP. VERBATIM: /OMITTED/ ADVISED ME TO REACH TO YOU REGARDING A POSSIBLE PRODUCT DEFECT WE DISCOVERED IN THE (B)(6) LAB YESTERDAY MORNING. THIS PRODUCT IS MANUFACTURED IN THE (B)(4) AND WE MADE /OMITTED/ AND /OMITTED/ AWARE OF THIS OBSERVATION YESTERDAY AFTERNOON. I WAS MADE AWARE OF THIS YESTERDAY AT 9:46 AM (CENTRAL) BY OUR LAB TECH, /OMITTED/. OBSERVATIONS (N=1): THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A .046¿ WIDE GROOVE LOCATED .083¿ FROM THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A THICKER SECTION OF PLASTIC LOCATED .377¿ FROM THE DISTAL END OF THE TIP. THIS SECTION OF THE DILATOR SHOULD GRADUALLY TAPER DOWN TO THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A DEFLECTED/OFF-CENTER DILATOR. DEFECT WAS DISCOVERED AFTER PERFORMING A LEAK TEST AND DISCOVERED THAT THIS PART COULD NOT PROVIDE AN AIR TIGHT SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025455 ↗
• MalfunctionDec 17, 2021Sharp Edges; Sharp Edges

  VERBATIM: ADVISED ME TO REACH TO YOU REGARDING A POSSIBLE PRODUCT DEFECT WE DISCOVERED IN THE PPA LAB YESTERDAY MORNING. THIS PRODUCT IS MANUFACTURED IN THE DR AND WE WERE MADE AWARE OF THIS OBSERVATION YESTERDAY AFTERNOON. I WAS MADE AWARE OF THIS YESTERDAY AT 9:46 AM (CENTRAL) BY OUR LAB TECH. OBSERVATIONS (N=1): THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A .046¿ WIDE GROOVE LOCATED .083¿ FROM THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A THICKER SECTION OF PLASTIC LOCATED .377¿ FROM THE DISTAL END OF THE TIP. THIS SECTION OF THE DILATOR SHOULD GRADUALLY TAPER DOWN TO THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A DEFLECTED/OFF-CENTER DILATOR. DEFECT WAS DISCOVERED AFTER PERFORMING A LEAK TEST AND DISCOVERED THAT THIS PART COULD NOT PROVIDE AN AIR TIGHT SEAL. LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025454 ↗
• MalfunctionDec 16, 2021Material Twisted/Bent; Material Twisted/Bent

  VERBATIM: ADVISED ME TO REACH TO YOU REGARDING A POSSIBLE PRODUCT DEFECT WE DISCOVERED IN THE PPA LAB YESTERDAY MORNING. THIS PRODUCT IS MANUFACTURED IN THE DR AND WE WERE MADE AWARE OF THIS OBSERVATION YESTERDAY AFTERNOON. I WAS MADE AWARE OF THIS YESTERDAY AT 9:46 AM (CENTRAL) BY OUR LAB TECH. OBSERVATIONS (N=1): THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A .046¿ WIDE GROOVE LOCATED .083¿ FROM THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A THICKER SECTION OF PLASTIC LOCATED .377¿ FROM THE DISTAL END OF THE TIP. THIS SECTION OF THE DILATOR SHOULD GRADUALLY TAPER DOWN TO THE DISTAL END OF THE TIP. THE DILATOR ON THE LOCKABLE ACCESS TIP HAS A MOLDING DEFECT WHICH IS A DEFLECTED/OFF-CENTER DILATOR. DEFECT WAS DISCOVERED AFTER PERFORMING A LEAK TEST AND DISCOVERED THAT THIS PART COULD NOT PROVIDE AN AIR TIGHT SEAL. LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017767 ↗