Medex 536040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688516336), received between Sep 15, 2023 and Jan 24, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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.

• MalfunctionJan 24, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT THE EXTENSION LINE WAS OCCLUDED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21229461 ↗
• MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE AT LUER LOCK CONNECTION WAS OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229357 ↗
• MalfunctionSep 15, 2023False Alarm; False Alarm

  IT WAS REPORTED THAT THE EXTENSION TUBING WAS REPEATEDLY BEEPING OCCLUDED. PATIENT IV WAS CHECKED AND WAS NOT OCCLUDED AT TIME. NEW EXTENSION TUBING UTILIZED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761405 ↗
• InjurySep 15, 2023Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT THE TUBING WAS FOUND TO BE DISCONNECTED AT THE END CLOSEST TO THE PUMP. END PIECE OF THE TUBING SEPARATED FROM THE TUBING ITSELF. UNSURE HOW LONG THIS WAS DISCONNECTED; THEREFORE LIPIDS HAD TO BE DISCARDED. PATIENT NEEDED ADDITIONAL FLUIDS HUNG TO ACCOUNT FOR MISSING LIPID VOLUME. IT IS UNKNOWN IF THERE WAS PATIENT HARM; "AN OPEN FLUID PATHWAY INCREASES RISKS FOR CATHETER ASSOCIATED BLOOD STREAM INFECTION".

  Patient problems: Insufficient Information

  MAUDE report 17761385 ↗
• InjurySep 15, 2023Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT THE LIPID TUBING BROKE APART DURING PICC DRESSING CHANGE. THIS REQUIRED AN ALTERATION IN FLUIDS GIVEN. IT IS UNKNOWN IF THERE WAS PATIENT HARM; "AN OPEN FLUID PATHWAY INCREASES RISKS FOR CATHETER ASSOCIATED BLOOD STREAM INFECTION".

  Patient problems: Insufficient Information

  MAUDE report 17761384 ↗

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,