CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
CryoValve SG Cryopreserved Pulmonary Human Heart Valve recalled
Artivion is recalling CryoValve SG Cryopreserved Pulmonary Human Heart Valve, distributed nationwide in the US. The recall was initiated on 6 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1545-2024
- FDA event ID
- 94250
- Recalling firm
- Artivion, Kennesaw, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Mar 2024
- FDA classified
- 16 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Other Bacterial Contamination
- Device type
- Heart & Vascular Devices
Timeline
| 6 Mar 2024 | Recall initiated by company | |
| 16 Apr 2024 | Classified by FDA | +41 days |
| 24 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Product as listed by the FDA
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Where it was distributed
US Nationwide distribution in the state of Ohio.
Questions about this recall
Why was it recalled?
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Which lots are affected?
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Where was it sold?
US Nationwide distribution in the state of Ohio.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Artivion
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CryoValve SG Pulmonary Human Heart Valve, SGPV00 recalled by Artivion | Artivion | Other | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Hemi-Artery recalled by Artivion | Artivion | Other | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |