LifeSPARC 5900-0000Recalls & 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.

1 other recall cover devices cleared under the same FDA submission (K183623, K211830); 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 18, 2026.

Recalls naming this device

1. Dec 5, 2022Class ITerminated

   A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

   Z-0926-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Jul 21, 2022Class ITerminated

   Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

   Z-1763-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183623, K211830. One submission often covers many models, so check the product and lot details in each record.

• Z-2465-2023 · Jun 30, 2023 · Open, Classified
  LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged com