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basixALPHA™ 00884450511305Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

All models of basixALPHA (5)

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

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.

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. Jun 10, 2021Terminated

    Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

    Z-2166-2021 · Root cause: Device Design · Recall details · FDA record ↗

Other Syringe, Balloon Inflation, Exempt devices

All Syringe, Balloon Inflation, Exempt devices →

Sources and updates

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