N/A 50-7245ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403502385), received between Aug 22, 2023 and Aug 20, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358835 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT A COMPLAINT WAS RECEIVED FROM A HOSPITAL ON 28/01/2026 REGARDING A PLEURX LOCKABLE DRAINAGE LINE. THE PATIENT CONNECTED THE DRAINAGE LINE ON (B)(6) 2026. THE PATIENT NOTICED THAT THE DRAINAGE LINE TUBING HAD DETACHED FROM THE LOCK HEAD. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CUSTOMER REPORTED THAT THE ISSUE WAS DETECTED DURING PATIENT USE, BUT CONFIRMED THAT NO PATIENT WAS IMPACTED AND NO INJURIES OCCURRED. THE ACCESS TIP DID NOT DISCONNECT FROM THE DRAINAGE LINE, AND THE CATHETER WAS LOCATED IN THE PLEURAL/CHEST AREA. THERE WAS NO LEAKAGE, AND THE PRODUCT INVOLVED WAS A DRAINAGE LINE, NOT A VACUUM BOTTLE. THE EVENT OCCURRED ON JANUARY 27, 2026, AND THE ISSUE WAS RESOLVED BY REPLACING THE DRAINAGE LINE WITH A NEW ONE. A VIDEO OF THE ISSUE IS AVAILABLE, BUT NO PHYSICAL SAMPLE CAN BE PROVIDED AS IT WAS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315984 ↗
• MalfunctionDec 9, 2024Disconnection; Disconnection

  THE ISSUES IS THAT THE TUBING IS DISCONNECTING FROM THE VALVE JUST BELOW THE POINT OF ATTACHMENT. THE CONNECTORS ARE STAYING PUT, BUT AT THE TOP END THE TUBING IS DISCONNECTING REGULARLY. THE ISSUE IS AIR LEAKAGE REQUIRING A MINIATRIUM. 21-NOV-2024 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION. ANSWERS ADDED IN FOLLOW UP TAB. REFER EMAIL ATTACHED. SHANMUGAPRIYA J. INTERNAL COMMENT - CONFIRMED WITH CUSTOMER THAT THE TUBING IS DISCONNECTING FROM THE LOCKABLE DRAINAGE LINE CONNECTOR - PLEASE REFER TO THE PICTURE, AFFECTED AREA IS CIRCLED IN RED. DEATH: NO. SERIOUS INJURY: NO. ERRONEOUS RESULTS: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. EXPOSURE TO BLOOD/BODILY FLUID: YES. THE PLEURX VALVE WAS OPENED WHEN IT HAPPENED HENCE, SOME FLUIDS WERE LET OUT. MEDICAL INT. OTHER THAN FIRST AID: NO. NEEDLE/PROBE STICK: NO. SAFETY ISSUE: YES. THE PATIENT NEEDS TO BE BROUGHT IN HOSPITAL TO MANAGE AIR LEAK. OTHER ACTIONS TAKEN: YES. A NEW LOCKABLE DRAINAGE LINE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879390 ↗
• InjuryJun 7, 2024Break; Break

  FOLLOW UP RESPONSE RECEIVED FOR PR# (B)(4) ON 14/MAY/2024: - REGARDING ISSUE REPORTED "SOME OF THESE POINTS HAVE BEEN FIXED WITH ADHESIVE TAPE BECAUSE ACCIDENTAL DISCONNECTION HAS OCCURRED TIME AND AGAIN, BUT WITHOUT CONSEQUENCE, AS IT WAS NOTICED IMMEDIATELY.". WHAT WAS THE PLEURX CATHETER CONNECTED TO? DID THEY USED THE PLEURX BOTTLE WHEN CONNECTING TO THE PATIENTS' CATHETER? - 50-7245A LOCKABLE DRAINAGE LINE WAS THE DISCONNECTION OCCURRED ACCIDENTAL? - NO, ACCESS TIP BROKE OFF. RESPONSE RECEIVED: ¿ WAS THE ACCESS TIP OF DRAINAGE LINE BROKEN OFF IN VALVE OF THE CATHETER? - YES. ¿ WHAT WAS THE IMPACT TO THE PATIENT? - AIR ENTRY INTO THE BODY / PNEUMOTHORAX. ¿ PLEASE PROVIDE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE ACCESS TIP BROKE OFF - 50-7245A, IF AVAILABLE - NOT KNOWN.

  Patient problems: Pneumothorax

  MAUDE report 19484058 ↗
• MalfunctionOct 23, 2023Contamination; Contamination

  MAT# 50-7245A LOT# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THREE OF THESE WERE CONTAMINATED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED REGARDING ORDER CONFIRMATION (B)(4), PO 12723762, ITEM 50-7245A, DRN LN LK PLEURX PERITX THREE OF THESE WERE CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984855 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DESCRIPTION OF THE PROBLEM (WHAT / WHY) - GLUE LINE BETWEEN THE TUBE AND THE CONNECTOR DOES NOT HOLD. HOW OFTEN DID THE DEFECT OCCUR - 1 MEDICAL INTERVENTION (OTHER THAN FIRST AID) - NOT REQUIRED. NEEDLE STICK/PROBE STICK - NOT REQUIRED. OTHER MEASURES TAKEN - YES SAFETY PROBLEM - NO PROBLEM SOLVED - YES HOW WAS THE PROBLEM RESOLVED / ADDITIONAL INFORMATION - REPLACE. PHOTO / SAMPLE AVAILABLE - NO SAFETY VALVE BROKEN / DAMAGED / DEFECTIVE - NO INFORMATION / NOT APPLICABLE. SAFETY CLAMP OPEN IF VALVE BROKEN. / DAMAGED. / D.. - NO INFORMATION / NOT APPLICABLE. SAFETY VALVE LUG BROKEN / DAMAGED - NO SPECIFICATION / NOT APPLICABLE. LOCKING TAB BROKEN / DAMAGED - NO INDICATION / NOT APPLICABLE. LEAKAGE - NO INDICATION / NOT APPLICABLE. SUCCESSFUL DRAINAGE - YES CONTACT WITH BLOOD / BODY FLUIDS - NO INDICATION / NOT APPLICABLE. CHANGE IN COURSE OF TREATMENT DUE TO EVENT - NO INDICATION / NOT APPLICABLE. TIME SPENT IN CATHETER - 2023-08-03 WHERE IS THE CATHETER LOCATED: IN THE ABDOMEN OR CHEST? - ABDOMEN CONNECTED DEVICE (PLEURX/PERITX/BRAND) - 50-7245A PROCEDURE PERFORMED BY - PATIENT PERFORMED IN - HOME ADDITIONAL INFORMATION - NONE / NOT RELEVANT RECEIVED ANSWERS - 14 AUG 2023 PLEASE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595561 ↗