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PREVENA PLUS™ PRE4010Recalls & reported problems

Kci USA, Inc. · PREVENA PLUS™ 125 THERAPY UNIT (14-DAY) WITH PREVENA PLUS™ 150ML CANISTER · Class 2

All models of PREVENA PLUS (2)

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. Jan 17, 2025Open, Classified

    Due to increase in complaints related to leak alarms

    Z-1175-2025 · Root cause: Device Design · Recall details · FDA record ↗

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page