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MRWire Guidewire

Contract Medical International GmbH · Model Angled MR Wire · UDI-DI 04251244500436

DQX Prescription

510(k) clearances

33,688

Adverse events (927 deaths)

258

Recalls

256

Facilities

Description

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The hydrophobic extrusion reduces intravascular friction in devices such as catheters. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and non-pyrogenic. The MRWire’s diameter is 0.035” (0.89 mm).

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LP	The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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.