FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Pulmonary Heart Valve
- Recall number
- Z-0065-04
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Pulmonary Heart Valve
- Status
- Terminated
- Initiated
- 2003-09-25
- Posted
- 2003-10-24
- Terminated
- 2004-05-06
- Reason
- Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
- Root cause
- Other
- Action
- The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification.
- Quantity
- 1 unit
- Distribution
- The tissue was distributed to one physician in CA.
- Lot, serial or model codes
- Donor #68830, Serial #8038836, Model #PV10
- 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