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Regard™ CV01005IRecalls & reported problems

Roi Cps, LLC · CV PART 1 BUNDLE · Class 2

Data updated Oct 13, 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 17, 2024Open, Classified

    Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

    Z-2685-2024 · Root cause: Pending · FDA record ↗

Other Cardiovascular Procedure Kit devices

All Cardiovascular Procedure Kit devices →

Sources and updates

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