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CardiaMend

Helios Cardio Inc. · Model CMUS-10NS-0816 · UDI-DI 00850023375018

PSQ Prescription
1
510(k) clearances
55
Adverse events (1 deaths)
2
Recalls
22
Facilities

Description

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm

Recalls

DateFirmReason
2023-12-06Baxter Healthcare CorporationCardiovascular 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
2023-12-06Baxter Healthcare CorporationCardiovascular 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

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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.