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TRUWAVE T433803ARecalls & reported problems

Edwards Lifesciences LLC · PRESSURE MONITORING SET · Class 2

All models of TRUWAVE (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

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

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. Oct 4, 2023Open, Classified

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

    Z-0413-2024 · Root cause: Device Design · Recall details · FDA record ↗

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Sources and updates

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