Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CryoValve Heart-valve, allograft

FDA Recall Z-0723-03 · Posted 2003-04-15

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeLMO
Date Initiated2003-03-19
Date Terminated2003-05-05
Product QuantityThere are two individual heart valve allografts.

Reason for Recall

The recipient of one of the kidneys from the donor has developed renal cell carcinoma.

Firm Action

Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification.

Root Cause

Other

Distribution Pattern

Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.

Official Source

View FDA Recall →

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

↑