Home › Device types › MIE
Heart-Valve, Allograft
FDA product code MIE · Class 3 · Unknown
0
Registered devices
474
Adverse events
80
Recalls
0
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-01-07 | CryoLife, Inc. | A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus. |
| 2008-03-26 | CryoLife, Inc. | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. |
| 2008-03-26 | CryoLife, Inc. | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. |
| 2007-04-17 | CryoLife, Inc. | Donor tissue was released prior to information received regarding a pericardial effusion. |
| 2007-04-17 | CryoLife, Inc. | Donor tissue was released prior to information received regarding a pericardial effusion. |
| 2006-01-27 | Cryolife Inc | Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection. |
| 2005-05-17 | Cryolife Inc | Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptan |
| 2005-05-17 | Cryolife Inc | Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptan |
| 2005-01-12 | Cryolife Inc | During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylo |
| 2004-12-17 | Cryolife Inc | During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in thei |
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