Teleflex's Arrow pulls guidewire-based PICC and JACC lines as FDA flags coating risk

Arrow International, part of Teleflex, has asked customers to stop using and distributing a group of vascular-access products, and the US Food and Drug Administration's device centre has put the matter on its Early Alert list. The company's letter went out on 5 November 2026. Neither the regulator's notice nor the material supplied to us gives any figure for units affected, revenue exposure or replacement timelines, so the commercial impact cannot yet be sized.

The problem lies in the polymer layer on the guidewire component. Teleflex has confirmed that the layer can swell unevenly when wetted with saline, so it may clump and come away. Particles could then enter the bloodstream and cause emboli. The FDA lists possible consequences including inflammation, clots, restricted blood supply, tissue injury, stroke, further procedures or death. As of 5 November, Arrow had reported no serious injuries or deaths connected to the issue.

The scope reaches beyond loose wires. It covers Arrow marked guidewires with the polymer coating on nitinol or stainless steel, and pressure-injectable catheters that include them. The catheters named are Arrowg+ard Blue Advance PICCs and JACCs in one-, two- and three-lumen formats with 80 cm or 130 cm wires, kits pre-loaded with the Arrow VPS Precision Stylet, and plain pressure-injectable PICCs, with or without those wires. The FDA points readers to a full product list.

Arrow is asking users to check stock at once, set aside matching items, stop using and passing them on, and arrange returns through Teleflex Customer Service. Anyone who has supplied affected product onward is asked to share the notice with their own customers. The FDA says its review continues and it will update its page if significant new information emerges.