Home › Elutia Med LLC › ProxiCor for Cardiac Tissue Repair
ProxiCor for Cardiac Tissue Repair
Elutia Med LLC · Model CMCV-064-401 · UDI-DI 00859389005041
DXZ
Prescription
1
510(k) clearances
1,499
Adverse events (215 deaths)
20
Recalls
52
Facilities
Description
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
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.