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EpiFaith CV

Flat Medical Co., Ltd. · Model FM-11SLR · UDI-DI 04719875599033

DQX Prescription

510(k) clearances

34,017

Adverse events (937 deaths)

258

Recalls

257

Facilities

Description

The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025" (0.64 mm) to 0.038"(0.96 mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.

Recalls

Date	Firm	Reason
2026-06-26	Galt Medical Corporation	Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
2026-05-08	Merit Medical Systems, Inc.	Due to unsealed portions of pouches.
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-02-25	Medline Industries, LP	The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2025-03-27	Galt Medical Corporation	Due to a potential open seal in the sterile barrier packaging.
2024-10-14	Cook Incorporated	Devices from the affected device lots have labels that state the incorrect expiration dates.
2024-10-08	Cook Incorporated	Affected device lots have labels that state the incorrect expiration dates.

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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.