PleurX 50-7210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403090660), received between Dec 11, 2020 and Apr 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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.

• MalfunctionApr 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN THE NURSE WANTED TO DRAIN THE PATIENT WITH A BOTTLE, THE TUBING (DRAINAGE LINE) FELL OFF THE BOTTLE NECK. SHE CLOSED THE CLAMP ON THE DRAINAGE LINE, TOOK A NEW BOTTLE AND THE SAME THING HAPPENED AGAIN. WAS THE DRAINAGE LINE DISCONNECTED FROM THE BOTTLE AT ANY POINT DURING THE DRAIN OR WAS IT NOTICED PRIOR TO DRAINAGE? YES, DURING THE DRAIN AND IT WAS NOTICED. IF IT'S BEFORE USE AND DID THEY ATTEMPT TO RECONNECT IT? DURING USE, AND NO ATTEMPT TO RECONNECT. NEED TO VERIFY THE LINE WAS DISCONNECTED PRIOR TO USE AND THE BOTTLE WAS NOT USED. BOTTLE WAS USED. WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER THE PLUNGER WAS PRESSED, ALL OF OUR PATIENTS ARE TRAINED. SO THIS SHOULD BE DONE CORRECTLY. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST? UNKNOWN. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? THERE IS NO PHOT AND NO SAMPLE AVAILABLE. WHAT WAS THE IMPACT TO THE PATIENT? NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021505 ↗
• MalfunctionAug 6, 2021Material Separation; Material Separation

  REF (B)(4),LOT 0001347543: WHEN PUTTING IN SUCTION, DIFFICULTY IN PIERCING THE MEMBRANE. DURING INSTALLATION IN THE PATIENT'S BED, THE TUBING DISCONNECTS FROM THE JAR. NO CONSEQUENCES FOR THE PATIENT BUT BLOOD EXPOSURE ACCIDENT FOR THE MEDICAL STAFF (THE DOCTOR WAS CONTAMINATED BY BLOOD FROM THE TUBING WHEN IT CAME OFF THE JAR). WAS THE DRAIN LINE DISCONNECTED FROM THE CYLINDER AT ANY TIME DURING DRAINAGE OR WAS IT NOTICED BEFORE DRAINAGE? DURING DRAINAGE (AFTER A FEW MINUTES) FOR INCIDENT 21-172. IF THE FAULT WAS NOTICED BEFORE USE AND WAS AN ATTEMPT MADE TO RECONNECT IT? WAS THE LINE DISCONNECTED BEFORE USE AND THE BOTTLE DISCARDED IMMEDIATELY? NO DURING USE FOR INCIDENT 21-172 WAS THE BOTTLE USED? YES BUT DISCARDED AFTER DISCONNECTION WITH THE TUBING FOR INCIDENT 21-172. WAS THE CLAMP PROPERLY CLOSED UNTIL THE PISTON WAS PRESSED? YES FOR ALL THREE INCIDENTS. WHERE WAS THE CATHETER LOCATED? CHEST. IS THERE A PHOTO SHOWING THE REPORTED DEFECT IF POSSIBLE? NO. WAS THERE A VACUUM PROBLEM? DIFFICULTY IN STRIKING THE MEMBRANE, POOR SUCTION FOR ALL 3 INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289222 ↗
• MalfunctionFeb 26, 2021Material Separation; Material Separation

  THE TUBE DISCONNECTED FROM THE BOTTLE. THEY CLOSE THE ROLLER CLAMP AND ACTIVATE THE VACUUM. WHEN THEY OPEN THE ROLLER CLAMP, THE TUBING FALLS OFF FROM THE BOTTLE. THEY IMMEDIATELY CLOSE THE ROLLER CLAMP. THEY USE A NEW BOTTLE AND ITS WORKING. FLUID IS DRAINED WITHOUT ANY PROBLEMS. FIRST THEY SUSPECT THAT AIR HAS ENTERED INTO THE PATIENT'S PLEURAL SPACE, BUT THE PATIENT IS NOT AFFECTED AND IS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11387878 ↗
• MalfunctionDec 11, 2020Material Separation; Material Separation

  TODAY, I WOULD LIKE TO POINT OUT A PROBLEM THAT I HAVE NOTICED SEVERAL TIMES ON THE PLEURX DEVICES, THE BAD FIXING OF THE TUBING ON THE BOTTLE ITSELF. WHEN YOU REALIZE THIS BEFORE YOU PUT THE SUCTION ON, WE CAN PUSH IT BACK AND THE VACUUM WILL NOT GO OUT. LOT NUMBER IS 0001347542. 30NOV2020: EMAIL SENT REQUESTING IF ADDITIONAL RESPONSE HAS BEEN RECEIVED. PER CUSTOMER RESPONSE; AT LEAST 2 TIMES, TUBING DISCONNECTED FROM THE BASE ON THE BOTTLE, AND ONCE BY PUSHING IT BACK BEFORE VACUUMING THE DRAINAGE COULD TAKE PLACE WITH GOOD SUCTION, (COPY GIVEN BACK TO THE DR (B)(6) PHARMACY) NO INCIDENCE ON THE CARE, NO PATIENT DAMAGE THIS WAS ESTABLISHED BEFORE CONNECTING THE VACUUM DEVICE TO THE PATIENT. IT IS A THORACIC PLEURX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10991342 ↗