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basixSKY™ Initial ReleaseRecalls & reported problems

Merit Medical Systems, Inc. · Class 2

2 open recalls name 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
2

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.

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 4, 2025Open, Classified

    Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

    Z-0533-2026 · Root cause: Process change control · FDA record ↗

  2. Aug 19, 2024Open, Classified

    Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

    Z-0071-2025 · Root cause: Packaging process control · FDA record ↗

Other Syringe, Balloon Inflation, Exempt devices

All Syringe, Balloon Inflation, Exempt devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.