Recall Z-2532-2024— Artivion, Inc

Name: FDA recall Z-2532-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-28

Class II · Ongoing

Class II FDA medical device recall by Artivion, Inc, initiated 2024-05-28. It names one FDA 510(k) clearance: K091626. 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 Tissue Allograft Prepared with SynerGraft (SG) Technology.. Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results..

Recalling firm: Artivion, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-28
Firm location: Kennesaw, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K091626 — CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCHCryolife, Inc.·cleared 2009-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.