5008X 03-5350-8Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

4 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.

Recalls naming this device

1. Aug 10, 2026Open, Classified

   Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

   Z-3087-2026 · Root cause: Component change control · FDA record ↗

2. May 11, 2026Open, Classified

   Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

   Z-2702-2026 · Root cause: Process control · FDA record ↗

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-3086-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
• Z-3085-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
• Z-3084-2026 · Aug 10, 2026 · Open, Classified
  5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
• Z-0936-2026 · Oct 25, 2025 · Open, Classified
  5008X CAREsystem +CLiC +CDX;