(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Reported: August 14, 2024 Initiated: May 28, 2024 #Z-2532-2024
Product Description
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Reason for Recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Details
- Recalling Firm
- Artivion, Inc
- Units Affected
- 2 arteries, 1 patch
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.. Recalled by Artivion, Inc. Units affected: 2 arteries, 1 patch.
Why was this product recalled? ▼
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2532-2024.
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