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Monarch® 00884450298039Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

All models of Monarch (6)

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. Aug 30, 2024Open, Classified

    Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

    Z-0058-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Other INJECTOR AND SYRINGE, ANGIOGRAPHIC devices

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Sources and updates

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