N/A 50-7265ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403502392), received between Mar 10, 2023 and Jan 5, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WERE ISSUES WITH THE PLEURX LOCKABLE DRAINAGE LINE KIT. DURING FOLLOW UP RESPONSE RECEIVED ON (B)(6) 2025, IT WAS FURTHER REPORTED THAT THE ¿MALE¿ CONNECTOR USED TO PLUG INTO THE PLEURX WAS NOT WATERPROOF AND CAME LOOSE EASILY, CAUSING LEAKAGE WHEN CONNECTING A PLEURX TO A PLEUR-EVAC. INITIALLY, THERE WAS NO VISIBLE DEFECT, BUT THE ISSUE BECAME APPARENT DURING USE. MULTIPLE KITS HAD TO BE OPENED BEFORE FINDING A FUNCTIONAL TUBING. THERE WAS A RISK OF PNEUMOTHORAX AND INFECTION SINCE THE SET UP WAS NOT A CLOSED SYSTEM ANYMORE. PATIENT PROBABLY KEPT HIS PLEURX CONNECTED TO A PLEUR-EVAC FOR LONGER. AN X-RAY WAS ORDERED, AND THE PATIENT WAS ALREADY ON ANTIBIOTICS. BASED ON FURTHER RESPONSE ON (B)(6) 2025 IT WAS FURTHER MENTIONED THE RESULTS OF THE X-RAY HAD A NEW SMALL PNEUMOTHORAX AND THAT THIS WAS POSSIBLY RELATED TO THE DEVICE FAILURE. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THE DEFECTIVE TUBING WAS REPLACED WITH INTACT TUBING TO CONTINUE CONTINUOUS DRAINAGE VIA THE PLEURX. THE PATIENT WAS ALREADY ON ANTIBIOTICS FOR INFECTION IN THE PLEURAL EFFUSION FOR SEVERAL DAYS AT THE TIME OF THE INCIDENT, SO THE ANTIBIOTICS WERE EXTENDED DUE TO THIS INCIDENT. IT WA

  Patient problems: Pneumothorax

  MAUDE report 23957141 ↗
• InjuryJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WERE ISSUES WITH THE PLEURX LOCKABLE DRAINAGE LINE KIT. DURING FOLLOW UP RESPONSE RECEIVED ON (B)(6) 2025, IT WAS FURTHER REPORTED THAT THE ¿MALE¿ CONNECTOR USED TO PLUG INTO THE PLEURX WAS NOT WATERPROOF AND CAME LOOSE EASILY, CAUSING LEAKAGE WHEN CONNECTING A PLEURX TO A PLEUR-EVAC. INITIALLY, THERE WAS NO VISIBLE DEFECT, BUT THE ISSUE BECAME APPARENT DURING USE. MULTIPLE KITS HAD TO BE OPENED BEFORE FINDING A FUNCTIONAL TUBING. THERE WAS A RISK OF PNEUMOTHORAX AND INFECTION SINCE THE SET UP WAS NOT A CLOSED SYSTEM ANYMORE. PATIENT PROBABLY KEPT HIS PLEURX CONNECTED TO A PLEUR-EVAC FOR LONGER. AN X-RAY WAS ORDERED, AND THE PATIENT WAS ALREADY ON ANTIBIOTICS. BASED ON FURTHER RESPONSE ON (B)(6) 2025 IT WAS FURTHER MENTIONED THE RESULTS OF THE X-RAY HAD A NEW SMALL PNEUMOTHORAX AND THAT THIS WAS POSSIBLY RELATED TO THE DEVICE FAILURE. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THE DEFECTIVE TUBING WAS REPLACED WITH INTACT TUBING TO CONTINUE CONTINUOUS DRAINAGE VIA THE PLEURX. THE PATIENT WAS ALREADY ON ANTIBIOTICS FOR INFECTION IN THE PLEURAL EFFUSION FOR SEVERAL DAYS AT THE TIME OF THE INCIDENT, SO THE ANTIBIOTICS WERE EXTENDED DUE TO THIS INCIDENT. IT WA

  Patient problems: Pneumothorax

  MAUDE report 23957138 ↗
• InjuryMar 10, 2023Complete Blockage; Device Handling Problem; Complete Blockage; Device Handling Problem

  IT WAS REPORTED BY THE CUSTOMER THEY HAVE NOT DRAINED IN 7 DAYS AND WHEN HOME HEALTH NURSE TRIED TO ACCESS IT, THEY WERE UNABLE TO GET ANY DRAINAGE. VERBATIM: PATIENT STATES SHE WENT OUT OF TOWN AND HAS NOT DRAINED HER PLEURX CHEST DRAIN FOR 7 DAYS. HER HOME HEALTH NURSE TRIED TO ACCESS IT TODAY, BUT SHE WAS UNABLE TO GET ANY DRAINAGE. RESPONSE: UPON DISCUSSION SHE STATES SHE WAS USING KITS FROM ROCKET MEDICAL. IT LOOKS LIKE THEY MAKE A PLEURAL CATHETER SO ITS POSSIBLE THE VALVE WAS DAMAGED USING INCOMPATIBLE ACCESSORIES. IT IS AFTER 330PM HERE. RECOMMENDED SHE HAVE HOME HEALTH NURSE CALL ME ASAP SO I CAN EXPLAIN WHAT SUPPLIES SHE MAY NEED TO REPAIR THIS CATHETER AND GET THEM OVERNIGHT SHIPPED FOR TOMORROW. SHE MAY NEED TO FLUSH THE CATHETER OR REPLACE THE VALVE AND SHE NEEDS TO BE EDUCATED TO USE PLEURX BRAND ACCESSORIES ON THIS CATHETER IN THE FUTURE. ON (B)(6) 2023 CALLED CUSTOMER TO FOLLOW UP ON REPORTED ISSUE. SPOKE WITH CUSTOMER AND SHE CONFIRMED ISSUE WAS THE CATHETER TUBING IN HER CHEST WAS CLOGGED. CUSTOMER HAD TO GO TO HOSPITAL TO HAVE THEM CLEAR THE CLOG. IT TOOK THEM 25 MINUTES TO CLEAR IT, THEY USED 4 SYRINGES 10CC OF SALINE AND WERE ABLE TO CLEAR THE TUBING. THE CUSTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522990 ↗