PleurX 50-7265Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403185199), received between Sep 30, 2021 and Sep 30, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CALLER PLACED THUMB OVER THE SHEATH AND THE PATIENT TOOK A DEEP BREATH PULLING AIR INTO THE PLEURAL SPACE. CALLER STATES SHE CONFIRMED WITH X-RAY THERE IS AIR IN THE PLEURAL SPACE. VERBATIM: CALLER STATES SHE PLACED A PLEURX CATHETER TODAY. SHE STATES SHE HAD HER THUMB OVER THE SHEATH AND THE PATIENT TOOK A DEEP BREATH PULLING AIR INTO THE PLEURAL SPACE. CALLER STATES SHE CONFIRMED WITH X-RAY THERE IS AIR IN THE PLEURAL SPACE. CALLER STATES SHE WILL NEED TO PLACE THE PATIENT TO WALL SUCTION FOR NOW. HOW DO WE ACHIEVE THIS? DO YOU HAVE AN ADAPTER FOR WALL SUCTION? RESPONSE: INFORMED CALLER THAT PRODUCT CODE 50-7265 IS THE PLEURX LOCKABLE DRAINAGE LINE KIT. EMAILED IFU FOR THEPLEURX LOCKABLE DRAINAGE LINE KIT. THE PLEURX LOCKABLE DRAINAGE LINE KIT (REF 50-7265) IS INDICATED FOR USE ONLY WITH THE PLEURX CATHETER FOR INTERMITTENT DRAINAGE. THE PLEURX LOCKABLE DRAINAGE LINE KIT IS USED TO DRAIN FLUID USING STANDARD WALL SUCTION, WATER SEAL DRAINAGE SYSTEM, GLASS VACUUM BOTTLE, OR OTHER APPROPRIATE METHOD (PORTABLE SUCTION). PLEASE REVIEW PAGE 12 OF THE PLEURX CATALOG FOR MORE INFORMATION ABOUT THE PLEURX LOCKABLE DRAINAGE KIT.

  Patient problems: Pneumothorax

  MAUDE report 12554402 ↗