5008X 04-3000-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861102624), received between Aug 14, 2026 and Aug 14, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K243505); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50255329 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243505. One submission often covers many models, so check the product and lot details in each record.

• Z-3084-2026 · Aug 10, 2026 · Open, Classified
  5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
• Z-3085-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
• Z-3086-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
• Z-3087-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
• Z-2702-2026 · May 11, 2026 · Open, Classified
  5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X
• Z-0936-2026 · Oct 25, 2025 · Open, Classified
  5008X CAREsystem +CLiC +CDX;