FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Allograft heart valve
- Recall number
- Z-0675-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Allograft heart valve
- Status
- Terminated
- Initiated
- 2003-01-23
- Posted
- 2003-03-21
- Terminated
- 2004-03-22
- 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. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A 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
- The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
- Lot, serial or model codes
- Model number SGPV00, Serial Number: 7291867, Donor #55899
- 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