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Open, Classified

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

FDA Recall Z-1545-2024 · Posted 2024-04-16

Recalling FirmArtivion, Inc
Recall StatusOpen, Classified
Product CodeOHA
Date Initiated2024-03-06
Product Quantity1 unit

Reason for Recall

The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

Firm Action

The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of Ohio.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)Cryolife, Inc. · 2010-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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