PleurX 50-7270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403420528), received between Jul 7, 2023 and Oct 5, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED BY CONSUMER THAT I UNDERSTAND YOU VE HAD OUR HOME HEALTH NURSES REACH OUT TO YOU REGARDING A BROKEN PLEUREX TIP. HAVE YOU SEEN ANYTHING LIKE THIS PREVIOUSLY? BOTH OF OUR BROKEN PLEUREX TIPS HAVE BEEN INSITU FOR OVER 6 MONTHS. IS THERE A CONTRAINDICATION TO INSERTION TIME? VERBATIM: COMPLAINT RECEIVED VIA EMAIL. QUESTION: I UNDERSTAND YOU'VE HAD OUR HOME HEALTH NURSES REACH OUT TO YOU REGARDING A BROKEN PLEUREX TIP. HAVE YOU SEEN ANYTHING LIKE THIS PREVIOUSLY? BOTH OF OUR BROKEN PLEUREX TIPS HAVE BEEN INSITU FOR OVER 6 MONTHS. IS THERE A CONTRAINDICATION TO INSERTION TIME?

  Patient problems: Insufficient Information

  MAUDE report 17875985 ↗
• InjuryJul 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT "CALL TRANSFERRED FROM PRODUCT COMPLAINTS AND AGENT REMAINED ON THE CALL. SURGEON REQUESTING TROUBLESHOOTING ASSISTANCE WITH THE PLEURX DEVICE FOR ON OF HER PATIENTS. SHE STATES THE PATIENT IS 90 YEARS OLD AND HAS A MALIGNANT PLEURAL EFFUSION. SHE HAD THE PLEURX DEVICE FOR ONE MONTH AND THE DEVICE STARTED LEAKING. SHE PLACED A PURSE STRING SUTURE AND CHANGED THE FREQUENCY OF THE DRAINING PROCEDURES, AND THE LEAKING DID IMPROVE BUT STATES NOW THE DEVICE IS CLOGGED. STATES THE PATIENT DOES NOT HAVE ANY SIGNS OF INFECTION AROUND THE CATHETER SITE". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CALL TRANSFERRED FROM PRODUCT COMPLAINTS AND AGENT REMAINED ON THE CALL. SURGEON REQUESTING TROUBLESHOOTING ASSISTANCE WITH THE PLEURX DEVICE FOR ON OF HER PATIENTS. SHE STATES THE PATIENT IS 90 YEARS OLD AND HAS A MALIGNANT PLEURAL EFFUSION. SHE HAD THE PLEURX DEVICE FOR ONE MONTH AND THE DEVICE STARTED LEAKING. SHE PLACED A PURSE STRING SUTURE AND CHANGED THE FREQUENCY OF THE DRAINING PROCEDURES AND THE LEAKING DID IMPROVE BUT STATES NOW THE DEVICE IS CLOGGED. STATES THE PATIENT DOES NOT HAVE ANY SIGNS OF INFECTION AROUND THE CATHETER SITE. EXPLAINED IF FLU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277510 ↗