PleurX 50-7245Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403174872), received between Feb 26, 2021 and Apr 12, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Device Handling Problem; Device Handling Problem

  VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PATIENT HAS PLEURX CATHETER IN SITU, SAME ORDERED TO BE CONNECTED TO PLEUROVAC FOR CONTINUOUS DRAINAGE AND REQUIRED A PLEURX LOCKABLE DRAINAGE LINE AS AN ADAPTOR BETWEEN THE DEVICES. PATIENT HAS HAD SYSTEM SET-UP THIS WAY FOR TWO DAYS. ON FEBRUARY 16TH, PATIENT WAS IN BED AND NOTICED HIS CHEST TUBE BECAME DISCONNECTED. PER THE PATIENT THE TUBE HAD GOTTEN SLIGHTLY CAUGHT ON HIS HAND AND HE HAD GENTLY PULLED IT BY ACCIDENT AND IT BECAME DISCONNECTED. STAFF CAME TO THE ROOM TO ASSESS THE SITUATION AND NOTED THAT THE CLEAR TUBING ON THE PLEURX LOCKABLE DRAINAGE LINE HAD FALLEN OUT OF THE BOTTOM OF THE WHITE CONNECTOR THAT IS USED TO CONNECT THE DEVICE TO THE PLEURX CATHETER (I.E. THE LOCKING MECHANISM WAS INTACT AND SECURE, BUT THE TUBING FELL OUT WHERE IT SHOULD NORMALLY REMAIN INTACT AND IMMOVABLE). THE DEVICE WAS REPLACED FOR ANOTHER ONE AND CONNECTIONS WERE ASSESSED TO ENSURE INTACT. IT IS CONSIDERED TO BE A PRODUCT CONCERN AS THE TUBE SHOULD NOT DISCONNECT AT THIS POINT WITH A SMALL AMOUNT OF FORCE. PATIENTS ARE OFTEN AMBULATING WITH THIS PRODUCT AND SO THERE IS A REASONABLE AMOUNT OF MOVEMENT, ETC AND THE POINT AT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096854 ↗
• InjuryJan 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING DRAINAGE OF PLEURX (50-7050), THE PATIENT MADE A SUDDEN MOVE, AND THE PLASTIC VALVE OF THE DRAINAGE LINE SET GOT DETACHED FROM THE LINE. 3 DIFFERENT EVENTS, SAME LOT NO. IN ONE EVENT, AIR GOT INTO THE BODY-PATIENT WAS DRAINED IMMEDIATELY. PIR WITH AEQ AVAILABLE IN THE ATTACHMENTS BELOW. PICTURES AVAILABLE IN THE ATTACHMENTS BELOW. WAS THE ACCESS TIP DISCONNECTED FROM DRAINAGE LINE, IF YES - DID THE ACCESS TIP REMAINS IN THE PATIENT VALVE? YES, IN THE INCIDENCE ON THE 27TH DECEMBER IT REMAINED WITHIN AND I COULD VERY DISTINCTLY HEAR THE AIR ENTERING THE LUNG. WAS ABLE TO IMMEDIATELY KINK THE TUBE AND PUT THE CLAMP THERE TO CLOSE THE TUBE. WHAT WAS THE PATIENT IMPACT FOR EVENT ONE TWO AND THREE? IN CASE ONE THE NURSE CLOSED THE TUBE AT ONCE. THE PATIENT WAS CONNECTED TO THE EMERSON-VACUUM SYSTEM. THE DOCTOR CHECKED THE PATIENT AND THE SATURATION WAS 97%, PLUS AN X-RAY WAS DONE. THERE WAS NO PNEUMOTHORAX AND THE PATIENT WAS REPORTED TO FEELING WELL. CASE 2: 25TH DECEMBER THE REPORT ONLY STATES THAT THE CONNECTOR BROKE AND THE PATIENT WAS RECONNECTED CASE 3: 27TH DECEMBER THAT WAS THE DAY I WAS PRESENT AND AS REPORTED ABOVE WE RECONNECTED THE PATIENT AS QUICKLY AS POSSIBLE TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240552 ↗
• MalfunctionMar 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE IS A CRACK IN THE TUBING WHEN PATIENTS COME BACK FROM IR. THERE HAVE BEEN MORE THAN 3 FAILURES ON THE LOCKABLE DRAINAGE LINE TUBING IN THE LAST 2 DAYS. THEY ARE HAVING TROUBLE WITH A CRACK IN THIS TUBING WHEN PATIENTS COME BACK FROM IR AND HAS AFFECTED 3 DIFFERENT DEPARTMENTS IF NOT MORE. IT CRACKS AT THE BASE OF THE LOCK WHEN IT ATTACHES TO THE PLEURX DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597129 ↗
• MalfunctionMar 23, 2021Material Separation; Material Separation

  TUBE CAME AWAY FROM LOCKABLE TIP. A PATIENT ON THE HEMATOLOGY WARD HAD A DRAINAGE LINE ATTACHED TO THE IPC, WHICH CONNECTED TO THE CHEST DRAIN. I WAS ADVISED THAT THE TUBING DISCONNECTED FROM THE ADAPTER. THE NURSES RECONNECTED IT AND TAPED THE SECTION BETWEEN THE TUBING AND ADAPTER TO ENSURE IT DIDN¿T DISCONNECT AGAIN. THEY ATTEMPTED TO ACCESS ANOTHER DRAINAGE LINE BUT HAD NO SUCCESS, AS THE SITUATION OCCURRED DURING NIGHT DUTY. I HAVE SENT YOU THE PICTURE WHERE THE LINE DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556258 ↗
• InjuryFeb 26, 2021Material Separation; Material Separation

  LINE DISCONNECTED FROM HUB. THE PATIENT HAD HIS PLUERX INSERTED ON (B)(6) 2021 THE LOCKABLE LINE FROM THE INSERTION KIT WAS CONNECTED TO AN UNDERWATER SEAL DRAIN. (B)(6) WAS SPEAKING TO THE PATIENT WHEN THIS HAPPENED. THE PATIENT JUST REPOSITIONED SLIGHTLY THEN UNINTENTIONALLY THE CLEAR TUBE/ LINE DISCONNECTED ON THE LOCKABLE LINE FROM THE WHITE HUB CONNECTION. SHE IMMEDIATELY CLAMPED THE CATHETER AND DISCONNECTED FROM THE LOCKABLE LINE AND THEN CAPPED THE PLUREX CATHETER. CHEST XRAY WAS DONE- FORTUNATELY PATIENT WAS OK , NO PNEUMOTHORAX- HE WENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Radiation Exposure, Unintended

  MAUDE report 11386447 ↗