Z-0325-2027

CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010

Name: Z-0325-2027 CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Creator: Artivion, Inc
Published: 2026-09-18
License: https://open.fda.gov/license/

Artivion, Inc / initiated 2026-09-18 / Open, Classified

FDA source

Recall record

Recall number: Z-0325-2027
Status: Open, Classified
Initiated: 2026-09-18
Posted: 2026-10-30
Recalling firm: Artivion, Inc
Product: CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded.
FDA root cause: Nonconforming Material/Component
Action: On 9/18/2026, the notification was delivered via mail to customer who was advised of the following: Available biomechanical and histological evidence does not indicate an increased risk that would warrant additional patient testing, enhanced clinical monitoring, or other clinical intervention beyond the patient's routine standard of care. Accordingly, prophylactic removal or surgical replacement of the already implanted tissue solely because of the donor-age nonconformance is not clinically warranted. Complete and return the response form via email to [email protected] Firm requests that any observed deficiency, performance concern, or other issue potentially associated with the tissue be reported to them vial email: [email protected] or phone: +1-770-419-3355
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of IL.
Product codes and lots: Serial/Donor Number: 12617554/177871, UDI-DI: 00877234000478, Shipped: 22May2024, Implanted: 05June2024

Product code DXZ

K101866Class IICryopatch Sg Pulmonary Human Cardiac PatchCryolife, Inc. / cleared 2010-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-03. View this recall on fda.gov (opens on fda.gov)