PharmacovigilanceOfficial

FDA issues early alert as Arrow recalls hydrophilic-coated spring wire guide products over coating detachment

🇺🇸 FDA MedWatch · Tue 10 Nov 2026

Teleflex subsidiary Arrow International has told customers to quarantine guidewires and PICC or JACC catheters whose hydrophilic coating may detach and release particles into the bloodstream.

The US Food and Drug Administration's Center for Devices and Radiological Health has published an Early Alert on a potentially high-risk issue involving Arrow International, a subsidiary of Teleflex Incorporated. Arrow has written to affected customers recommending that certain products containing Spring Wire Guide components be removed from where they are used or sold.

According to the company, there is a quality issue with the hydrophilic-coated Spring Wire Guide components. Teleflex has confirmed that the coating may swell inconsistently when hydrated with saline, causing it to clump and potentially detach. Detached coating could release particles into the bloodstream and raise the risk of emboli. The FDA notes that hydrophilic polymer emboli may lead to inflammation, thrombosis, ischemia, tissue injury, stroke, further intervention or death. As of 5 November 2026, Arrow had reported no serious injuries or deaths linked to the issue.

The affected range covers Arrow Marked Guidewires with a hydrophilic coating on nitinol or stainless steel, plus a number of pressure-injectable catheters that contain these guidewires. These include Arrowg+ard Blue Advance PICCs and JACCs in one-, two- and three-lumen versions, with 80 cm or 130 cm wires, and kits pre-loaded with the Arrow VPS Precision Stylet. Plain pressure-injectable one-, two- and three-lumen PICCs, with and without 80 cm or 130 cm wires, are also listed. The FDA refers readers to a full list of affected products. The guidewires help place catheters in blood vessels, while the catheters deliver medicines and fluids and allow blood sampling.

Arrow sent its customer letter on 5 November 2026. It asks users to check inventory immediately, stop using and distributing affected product, quarantine it, and contact Teleflex Customer Service to arrange returns. Customers who passed on affected product should provide the recall notice to their own customers. US customers with adverse reactions, quality problems or questions can contact Arrow at Recalls@teleflex.com or 1-866-396-2111. Adverse events and quality problems can also be reported to MedWatch. The FDA says it is still reviewing the information and will update its page as significant new information emerges.

What it means for your team

  • Check inventories and clinical areas for the listed Arrow guidewires and PICC/JACC products, and consult the full affected-product list on the FDA page to confirm matches.
  • Quarantine matching stock, stop use and distribution, and arrange returns through Teleflex Customer Service as set out in the 5 November letter.
  • Distributors and healthcare organisations that passed on affected product should forward the recall notice to downstream customers.
  • Vigilance teams should report any adverse reactions or quality problems to Arrow and MedWatch, and monitor the FDA page for updates.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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