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

On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

FDA Recall Z-3108-2017 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeNPT
Date Initiated2014-02-12
Date Terminated2019-11-05
Product Quantity5 units

Reason for Recall

Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

Firm Action

On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.

Root Cause

Other

Distribution Pattern

US Distribution to the state of : Illinois

Official Source

View FDA Recall →

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

↑