CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Artivion, Inc · 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 ye…
Open FDA's page for this record- Cfres ID
- 223129
- Product res number
- Z-0325-2027
- Event date initiated
- 2026-09-18
- Event date posted
- 2026-10-30
- Recall status
- Open, Classified
- Res event number
- 100012
- Product code
- DXZ
- Product description
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
- Code info
- Serial/Donor Number: 12617554/177871, UDI-DI: 00877234000478, Shipped: 22May2024, Implanted: 05June2024
- Firm FEI number
- 3001451326
- Recalling firm
- Artivion, Inc
- Address 1
- 1655 Roberts Blvd Nw
- City
- Kennesaw
- State
- GA
- Postal code
- 30144-3632
- Additional info contact
- Rochelle Maney 678-290-4531
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 1
- Distribution pattern
- US Nationwide distribution in the state of IL.
- 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.
- 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 fieldassurance@artivion.com Firm requests that any observed deficiency, performance concern, or other issue potentially associated with the tissue be reported to them vial email: fieldassurance@artivion.com or phone: +1-770-419-3355
- K numbers
- K101866
- Harmonized identifiers (openFDA)
- Device name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3470
- Device class
- 2
- K number
- K140789, K914448, K052416, K881508, K041716, K770835, K011487, K101740, K823345, K152127, K060396, K151865, K012098, K973178, K983602, K931386, K112683, K791792, K842066, K200955, K022093, K992776, K031948, K081438, K905073, K953425, K090637, K821717, K063349, K122306, K994032, K964467, K111187, K930950, K821532, K020233, K091626, K962342, K942010, K972201 +50 more
- Registration number
- 3018094310, 3004365956, 3010097171, 3009672666, 3045857302, 1054241, 3017102971, 1220948, 3045042524, 1835959, 3002924436, 1060680, 3041851334, 9612501, 3002719998, 9680759, 2320762, 1018233, 1063481, 3007284313, 1640201, 3007791599, 1000393132, 3010452421, 2210968, 1018470, 2015691, 3011137372, 1221601, 1055236, 9612515, 3006017180, 1043214, 3031160994, 2648650, 3005636544, 3006082230, 1526611, 3006638824, 2183620 +15 more
- FEI number
- 3018094310, 3004365956, 3010097171, 3009672666, 3045857302, 1000112968, 3017102971, 1220948, 1000306139, 3045042524, 3002924436, 3041851334, 3002719998, 1018233, 3002707083, 3007284313, 3001451326, 3007791599, 1000393132, 3003040625, 3010452421, 2210968, 1018470, 2015691, 1221601, 1043214, 3006017180, 3003495548, 3002807088, 3031160994, 1000112877, 3005636544, 2648650, 3006082230, 1526611, 3003870583, 3006638824, 2183620, 3005381997, 1047843 +15 more