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CardioGRAFT-MC™
LIFENET HEALTH · Model DPPGK7031 · UDI-DI 00889858617536
DXZ
Prescription
10
510(k) clearances
1,498
Adverse events (215 deaths)
20
Recalls
52
Facilities
Description
Decellularized Pulmonary Artery Patch - Thick
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-09 | Glycar SA Pty., Ltd. | The impacted lot may not meet the required tensile strength specification. |
| 2025-10-09 | Glycar SA Pty., Ltd. | The impacted lot may not meet the required tensile strength specification. |
| 2024-05-28 | Artivion, Inc | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2021-07-08 | Vascutek, Ltd. | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| 2020-11-10 | CryoLife, Inc. | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was al |
| 2018-09-06 | CryoLife, Inc. | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch l |
| 2018-05-14 | CryoLife, Inc. | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. |
| 2018-01-03 | GETINGE US SALES LLC | A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product insid |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.