Home › Elutia Med LLC › Tyke, Patch, Pledget and Intracardiac

Tyke, Patch, Pledget and Intracardiac

Elutia Med LLC · Model CMCV-098-204 · UDI-DI 00859389005102

DXZ Prescription

510(k) clearances

1,499

Adverse events (215 deaths)

Recalls

Facilities

Description

Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.

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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Data 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.