Medex MX9543Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688503091), received between Mar 11, 2025 and Jun 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K070340, K942377); 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.

Recalls naming this device

1. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0197-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  THE DEVICE WAS RETURNED BECAUSE THE TRANSTAR@ KIDS KIT 19IN CLOSED BLOOD SAMPLE KIT 10/CA TUBING WAS CRACKED. DURING THE PHYSICAL INSPECTION, AIR IN THE LINE AND LEAKAGE WERE OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN, AND NO PATIENT HARM OR ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301780 ↗
• MalfunctionJun 20, 2025Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  THE DEVICE WAS RETURNED BECAUSE THE TRANSTAR@ KIDS KIT 19IN CLOSED BLOOD SAMPLE KIT 10/CA TUBING WAS CRACKED. DURING THE PHYSICAL INSPECTION, AIR IN THE LINE AND LEAKAGE WERE OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN, AND NO PATIENT HARM OR ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301776 ↗
• MalfunctionMar 11, 2025Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE TUBING WAS CRACKED, RESULTING IN AIR IN THE LINE AND LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573503 ↗
• MalfunctionMar 11, 2025Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE TUBING WAS CRACKED, RESULTING IN AIR IN THE LINE AND LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070340, K942377. One submission often covers many models, so check the product and lot details in each record.

• Z-0186-2025 · Sep 24, 2024 · Open, Classified
  medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
• Z-0184-2025 · Sep 24, 2024 · Open, Classified
  medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
• Z-0185-2025 · Sep 24, 2024 · Open, Classified
  medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1