PleurX 50-7700Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403231520), received between Mar 25, 2022 and May 27, 2026 — classified as 4 injuries, 4 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PLEURX LOCKABLE DRAINAGE LINE TUBING BECAME DISCONNECTED FROM THE LUER LOCK TO CONNECT TO THE CATHETER. A NEW TRAY WAS OPENED TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303211 ↗
• MalfunctionFeb 5, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED BY CUSTOMER THAT THE BOX WAS DELIVERED WET ALONG WITH THE PRODUCT ON THE INSIDE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM WANTING TO DO A RETURN FOR (1EA ) KIT CATH PLEURAL STARTER 1000ML. THE BOX WAS DELIVERED WET ALONG WITH THE PRODUCT ON THE INSIDE. REF# 50-7700.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315879 ↗
• InjuryDec 24, 2024Migration; Migration

  IT WAS REPORTED BY CUSTOMER THAT CUFF OF PLEURX IS OUT OF SKIN. VERBATIM: CUFF OF OLEURAX IS OUT OF SKIN; PATIENT DOESN¿T HAVE EXPLANATION; EXCHANGING CATHETER TO REDUCE RISK OF INFECTION OPPORTUNITY; NO INFECTION REPORTED AS OF NOW. CUSTOMER RESPONSE ON DEC 18, 2024: 1. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT? AN ASSESSMENT WAS DONE USING IMAGING TO DETERMINE POTENTIAL MISPLACEMENT OF CATHETER/OCCLUSION. 2. HOW WAS THE ISSUE RESOLVED? I WAS TOLD THE INTENDED PLAN WAS TO REPLACE THE PLEURX. 3. WAS CATHETER REPLACEMENT NECESSARY DUE TO A LOOSE CUFF? THE REPLACEMENT WAS OUT OF CAUTION TO MINIMIZE INFECTION RISK. 4. HOW WAS THE ISSUE RESOLVED? PLAN MENTIONED WAS TO REPLACE PLEURX CATHETER. 5. WHAT WAS THE IMPACT TO THE PATIENT? REPLACEMENT OF NEW PLEURX. 6. WHAT IS THE LOT NUMBER AND MATERIAL NUMBER ASSOCIATED WITH THE REPORTED ISSUE? UNK. 7. HOW LONG HAS THE CATHETER BEEN IN PLACE? NO SPECIFIC TIME REPORTED BUT NOT HE PATIENTS FIRST PLEURX AND WAS SHARED IT WAS NOT PLACED FOR LONG. 8. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST? CHEST. 9. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21009619 ↗
• InjuryNov 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY CUSTOMER THAT WHILE PUTTING IN THE PEEL-AWAY INTRODUCER IT WOULDN'T ADVANCE, IT BENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I AM THE OR DIRECTOR AT (B)(6). AND WE HAVE A PULMONOLOGIST DR. (B)(6) THAT WAS USING YOUR PLEURAL CATHETER KIT AND WHILE PUTTING IN THE PEEL-AWAY INTRODUCER IT WOULDN'T ADVANCE, IT BENT. I HAVE INCLUDED A PICTURE IN THIS EMAIL. THE SURGEON WAS UPSET AND STATED THIS HAS NEVER HAPPENED BEFORE AND TO LET THE COMPANY KNOW. I HAVE THE WRAPPER THAT THE KIT CAME IN- LOT NO. 0001569519. CUSTOMER RESPONSE ON (B)(6)2024. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? - . I DIDN'T HAVE ANY ISSUES INSERTING THE DILATOR INTO THE PLEURA BUT WHEN I TRIED TO PASS THE PLEUREX INTO THE DILATOR IT WOULDN'T GO IN AND THIS WAS BECAUSE DILATOR KINKED AT MULTIPLE LEVELS. WHAT WAS THE IMPACT TO THE PATIENT? - I HAD TO STOP THE PLEUREX AND PATIENT HAD TO GO HOME WITHOUT THE PLEUREX. LUCKILY, PATIENT HAD NO COMPLICATIONS DURING THAT PROCEDURE. BUT PATIENT CAME BACK TO HOSPITAL IN FEW DAYS WITH PLEURAL EFFUSION AGAIN. THIS LEAD TO AN UNNECESSARY READMISSION. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642279 ↗
• InjurySep 20, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT NO FLUID WAS COMING OUT FROM THE VALVE, BUT FLUID COMING OUT AROUND THE INSERTION SITE. IR DID FLOURO AND NOTICED THAT THE CATHETER HAD SEPARATED 1 CM BELOW THE CUFF. VERBATIM: AFTER PLACING PLEURX CATHETER, ITEM CODE 50-7000B, NO FLUID WAS COMING OUT FROM THE VALVE, BUT FLUID COMING OUT AROUND THE INSERTION SITE. IR DID FLOURO AND NOTICED THAT THE CATHETER HAD SEPARATED 1 CM BELOW THE CUFF. PER THE TEAM, THEY DID NOT NOTICE ANY DEFECT PRIOR TO PLACING OR DURING TUNNELING. THE BROKEN PORTION OF THE CATHETER WAS IN THE TUNNEL TRACK SO IT WAS EASILY RETRIEVED. THEY REMOVED THE TWO CATHETER PIECES AND REPLACED WITH A NEW PLEURX CATHETER. ADDITIONAL INFORMATION RECEIVED ON 04SEP. 1. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? WAS NOT OBSERVED DURING CASE OR BEFORE, CATHETER APPEARED TO NOT TO HAVE ANY DEFECTS, FOUND IT ON FLUORO POST PLACEMENT 2. WHAT WAS THE IMPACT TO THE PATIENT? NO HARM, JUST DELAY IN CARE, THEY OPENED ANOTHER PLEURX TRAY AND INSERTED THE NEW PLEURX CATHETER WITH NO ISSUES. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE, JUST DELAY, SEE NOTE ABOVE 4. PROVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268759 ↗
• InjuryFeb 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CONSUMER THAT PATIENT WAS HAVING A PROCEDURE TO REMOVE THE PLEURX CATHETER. THE CATHETER WAS STUCK IN THE PATIENT AND COULD NOT BE REMOVED. THORACIC SURGERY HAD TO BE CALLED IN TO INTERVENE AND GET THE CATHETER OUT OF THE PATIENT. VERBATIM: PATIENT WAS HAVING A PROCEDURE TO REMOVE THE PLEURX CATHETER. THE CATHETER WAS STUCK IN THE PATIENT AND COULD NOT BE REMOVED. THORACIC SURGERY HAD TO BE CALLED IN TO INTERVENE AND GET THE CATHETER OUT OF THE PATIENT. 50-7000B, LOT 0001520433. DESCRIBE PATIENT / HCP / USER IMPACT : THORACIC SURGEON HAD TO BE CALLED IN TO PROCEDURE TO INTERVENE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18669214 ↗
• MalfunctionMay 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: DISCONNECTED-CUFF FROM CATHETER 06-MAY-2022 - PER CLINICIAN : A PATIENT IN OUR CLINIC HAD A PLEURX DRAIN PLACED (B)(6) 2021. WHEN IT WAS REMOVED FRIDAY (B)(6) 2022, THE CUFF WAS NO LONGER PRESENT ON THE DRAIN. THE AREA UNDER THE SKIN NEAR THE INSERTION SITE WAS CHECKED AND THE CUFF COULD NOT BE FOUND. THE PATIENT IS FOLLOWING UP AT THE END OF MAY, BUT HE WILL CALL IF HE EXPERIENCES ANY SYMPTOMS. THE AREA WHERE THE CUFF WAS PRESENT, THERE IS NOW A NOTCH AND HORIZONTAL STRIATIONS. I WAS TOLD BY A REPRESENTATIVE, ANDREW, THAT I COULD BE SHIPPED A BOX, SO I CAN SEND BACK THE PLEURX DRAIN FOR INSPECTION. PER EMAIL 09-MAY-2022 CAN YOU PLEASE VERIFY THE LOT NUMBER # YOU PROVIDED? WE CAN¿T SEEM TO LOCATE IT IN OUR SYSTEM. LOT NO.: 0001430062. CAN YOU PLEASE PROVIDE THE PRODUCT NUMBER? MODEL/CAT NO.: 50-7700. WOULD YOU BE ABLE TO PROVIDE DOB AND SEX OF PATIENT? (B)(6) 1947 MALE. WOULD YOU HAPPEN TO HAVE PHOTOS YOU CAN SHARE? WOULD YOU HAPPEN TO HAVE SAMPLES TO RETURN? IF SO, PLEASE VERIFY IF THE PRODUCT IS CONTAMINATED. YES, HAVE CATHETER IN BIOHAZARD BAG SINCE IT WAS INSIDE THE PATIENT. WAS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437640 ↗
• MalfunctionMar 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT EXPIRED PRODUCT. QUESTION: REP CALLED AND STATED SHE RECEIVED A CALL FROM /OMIT/ AT (B)(6) MEMORIAL ABOUT A PHYSICIAN PLACING AN EXPIRED PLEURX. THE PRODUCT EXPIRED ON 12/31/2021 BUT SHE HAS NO OTHER INFORMATION FROM THE CUSTOMER. PLEASE CONTACT /OMIT/ FOR ALL INFORMATION. RESPONSE: EXPLAINED THE CASE NEEDED TO BE REPORTED TO FIELD ASSURANCE. BARD/BD CANNOT RECOMMEND PLACING ANY PRODUCT PAST THE LABELED EXPIRATION DATE. WE HAVE NO SPECIFIC INFORMATION OR TESTING ON USE OF AN EXPIRED PRODUCTS. WE CONSIDER THE KIT CONTENTS TO BE STERILE AS LONG AS THE PACKAGING IS INTACT WITH NO SIGNS OF DAMAGE. THE PHYSICIAN WILL HAVE TO DETERMINE RISK VS BENEFITS OF LEAVING THE PRODUCT IN THE PATIENT. PAR WAS SET TOO HIGH FOR CLINICAL NEED. OVERSTOCK AREA DESIGNATED WITH OVERSTOCK SUPPLY. SUPPLY CHAIN STAFF PULLED FROM OVERSTOCK PALLET TO REPLENISH DEPARTMENT. STAFF PULLED EXPIRED PRODUCT. EXPIRED PRODUCT WAS PLACED IN PATIENT. PHYSICIANS STATED THE PATIENT¿S CONDITION WOULD NOT BE SUITABLE FOR AN EXCHANGE. DECISION WAS MADE TO LEAVE EXPIRED CATHETER IN PLACE. SUPPLY CHAIN NOTIFIED OF EXPIRED PRODUCT IN DEPARTMENT. EXPIRED PRODUCT WAS PULLED THE SAME DAY. INTERNAL INCIDENT REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904441 ↗