FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: CryoValve, Pulmonary Valve & Conduit
- Recall number
- Z-1524-2008
- Recalling firm
- CryoLife, Inc.
- Product
- CryoValve, Pulmonary Valve & Conduit
- Status
- Terminated
- Initiated
- 2008-03-26
- Posted
- 2008-09-01
- Terminated
- 2010-01-12
- Reason
- Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- Root cause
- Material/Component Contamination
- Action
- Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
- Quantity
- 1 tissue
- Distribution
- Hospitals in DE, TN
- Lot, serial or model codes
- Donor number 87732, Serial number 8895391
- 510(k) numbers
- ["K033484"]
- PMA numbers
- not on file
- Product code
- MIE
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28