FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Allograft heart valve
- Recall number
- Z-0676-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Allograft heart valve
- Status
- Terminated
- Initiated
- 2003-01-30
- Posted
- 2003-03-21
- Terminated
- 2003-07-16
- Reason
- An allograft associated with this donor has been linked to an alleged infection.
- Root cause
- Other
- Action
- A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction.
- Quantity
- 1 unit
- Distribution
- One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
- Lot, serial or model codes
- Model number PV00, Serial Number: 7255205, Donor #56190
- 510(k) numbers
- not on file
- 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