Medex 537240PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688516275), received between Apr 10, 2023 and Apr 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K831087); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY NEPHROLOGY SERVICE THAT WHEN PRIMING THE LINE WITH PHYSIOLOGICAL SOLUTION AN OBSTRUCTION WAS IDENTIFIED. CHANGE OF EQUIPMENT WAS NEEDED. THE SAMPLES WERE NOT IN TOUCH WITH THE PATIENTS. THE MEDICAL STAFF NOTICED THE OBSTRUCTION WHILE PURGING AND PREPARING THE EQUIPMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722274 ↗
• MalfunctionApr 12, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT WAS INFUSED WITH ADRENALINE, HOWEVER THE MEDICATION WAS NOT FLOWING THROUGH DUE TO AN OBSTRUCTION IN THE LINE. THE MEDICAL STAFF NOTICED THE OBSTRUCTION WHILE PURGING AND PREPARING THE EQUIPMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722273 ↗
• MalfunctionApr 12, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WHEN PURGING THE EQUIPMENT, THE SOLUTION WAS NOT FLOWING THROUGH THE INFUSION LINE. CHANGE OF LINE WAS PERFORMED. THE SAMPLES WERE NOT IN TOUCH WITH THE PATIENTS. THE MEDICAL STAFF NOTICED THE OBSTRUCTION WHILE PURGING AND PREPARING THE EQUIPMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722271 ↗
• MalfunctionApr 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT WAS INFUSED WITH ADRENALINE, HOWEVER THE MEDICATION WAS NOT FLOWING THROUGH DUE TO AN OBSTRUCTION IN THE LINE. THE MEDICAL STAFF NOTICED THE OBSTRUCTION WHILE PURGING AND PREPARING THE EQUIPMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709597 ↗
• MalfunctionApr 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AT THE BEGINNING OF INFUSION, NO MEDICATION FLOWING THROUGH. THE MEDICAL STAFF NOTICED THE OBSTRUCTION WHILE PURGING AND PREPARING THE EQUIPMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709592 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K831087. One submission often covers many models, so check the product and lot details in each record.

• Z-1730-2015 · May 4, 2015 · Terminated
  Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box,