FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall of implanted cardiac tissue products with quality control failures. Although the products are high-risk and already implanted, no injuries or illnesses have been reported, qualifying this as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Artivion, Inc. has recalled two types of CryoPatch SG cardiac tissue patches: the Pulmonary Human Cardiac Hemi-Artery Patch (SGPH00) and the Pulmonary Human Cardiac Branch Patch (SGP020). These are cryopreserved, decellularized cardiac tissue allografts used in cardiac surgeries.
The recall was initiated because the grafts were approved, released, shipped, and implanted despite having invalid test results. This represents a failure in the approval and quality control process prior to distribution and implantation.
The affected grafts were distributed nationwide to hospitals in California, the District of Columbia, Florida, and New York. Patients who received implants of the affected product batches may be at risk.
Patients who believe they received one of the recalled patches should contact their implanting healthcare provider or surgeon immediately for evaluation and guidance. Healthcare providers should review patient records to identify affected recipients.
The recalled product
- Product
- (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 Tis
- Manufacturer
- Artivion, Inc
- Hazard
- invalid-test-results
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- (1) SGPH00 - Serial #12071128
- exp. 17Nov2027
- and serial #11586249
- exp. 04May2025
- UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767
- exp. 15Aug2028
- UDI-DI: 00877234000485.
Distribution
Distributed nationwide across the United States.
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