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Prelude Roadster™ 00884450531921Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

All models of Prelude Roadster (33)

Data updated Oct 18, 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 18, 2026.

Recalls naming this device

  1. May 22, 2024Class IIOpen, Classified

    Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

    Z-2218-2024 · Root cause: Device Design · Recall details · FDA record ↗

Other Dilator, Vessel, For Percutaneous Catheterization devices

All Dilator, Vessel, For Percutaneous Catheterization devices →

Sources and updates

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