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Arrow International, a Teleflex subsidiary, advised affected customers to stop using and distributing a list of guidewires and catheter products containing Spring Wire Guide components, quarantine them and arrange returns. The FDA says a coating may swell inconsistently in saline and detach, potentially releasing particles into the bloodstream. As of Nov. 5, 2026, the company reported no serious injuries or deaths associated with the issue.
The U.S. Food and Drug Administration has issued an Early Alert after Arrow International, a Teleflex subsidiary, advised customers to stop using and distributing specified guidewire and catheter products containing Spring Wire Guide components, quarantine their stock and return it. The potential issue is that a hydrophilic coating may clump and detach after contact with saline, possibly releasing particles into the bloodstream; the FDA says it is reviewing the information.
According to the FDA, Arrow International sent an affected-customer letter on Nov. 5, 2026, recommending that customers immediately check inventory, cease use and distribution of the listed products, and quarantine them. Customers are instructed to contact Teleflex Customer Service to arrange returns and to give a copy of the recall notice to customers who received impacted products.
The affected products include Arrow-marked hydrophilic-coated guidewires made with nitinol or stainless steel, as well as multiple pressure-injectable PICC and JACC catheter configurations. Some listed kits include a guidewire or Arrow VPS Precision Stylet. The FDA alert provides a product-by-product list; facilities should use that list and the company notice to identify affected inventory rather than relying on a general product description.
Arrow International stated that the concern involves a potential quality issue with supplied hydrophilic-coated Spring Wire Guide components. The company said the coating may swell inconsistently when hydrated with saline, causing clumping and possible detachment. The FDA describes the possible consequence as particle release into the bloodstream. It says polymer emboli may lead to serious health consequences, but that is a potential risk, not a report that those outcomes have occurred in this case.
Why Coating Detachment Matters
The alert concerns devices used in vascular access and catheter placement. Coated guidewires help place catheters in blood vessels, while the affected catheter products are used to deliver medicines and fluids and collect blood samples. A defect in a component used during those procedures could affect patients as well as hospitals, clinics and distributors holding the products.
The FDA lists possible consequences if coating particles enter the bloodstream, including inflammation, thrombosis, ischemia and tissue injury, as well as stroke, further intervention or death. Those are risks identified by the agency, not confirmed injuries linked to this issue. The FDA says Arrow had reported no serious injuries or deaths associated with it as of Nov. 5, 2026.
The immediate action is directed at the supply chain: identify affected stock, stop using or distributing it, quarantine it and coordinate its return. Sharing the notice with customers who received impacted product is intended to help extend the response beyond the original recipients.
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Products and Alert Timeline
The FDA’s Center for Devices and Radiological Health issued the notice as an Early Alert for a potentially high-risk medical-device issue. The agency says it will update the public page when significant new information becomes available and is currently reviewing information about the issue. The notice links to company-provided material, which the FDA posts as a public service.
The named products span standalone guidewires and several pressure-injectable catheter lines. The list includes one-, two- and three-lumen PICCs, versions with 80-centimeter or 130-centimeter wires, and certain Arrowg+ard Blue Advance configurations. It also includes selected JACC products and preloaded PICC kits. The specific product configuration matters: the alert does not say that every Arrow catheter or guidewire is affected.
The FDA describes these devices’ role in catheter placement and vascular access, but the available alert does not provide a complete account of how the quality issue arose or when each affected product was distributed. Its instructions direct customers to the company for return arrangements and to the FDA page for further updates.
Open Questions on Risk and Scope
The FDA alert does not state how many devices or customers are affected, how many units have been returned, or whether the company has identified a particular production period or lot range. It also does not provide detailed findings from the agency’s review. Those details remain unreported in the available notice.
The potential coating failure and its possible consequences should not be confused with confirmed patient harm. The FDA reports that, as of Nov. 5, 2026, Arrow International had reported no serious injuries or deaths associated with the issue. The notice does not say whether there were less serious adverse events, nor does it establish that coating particles detached in every affected device.
It is also not clear from the alert whether additional products will be added to the list or what technical changes, if any, will address the issue. The agency says it will share significant new information as it becomes available.
Quarantine, Returns and FDA Updates
Customers should check inventory against the full affected-product list, stop using and distributing any listed devices, and quarantine them. Arrow’s letter directs customers to contact Teleflex Customer Service to return affected product and to pass the notice to customers who received impacted devices. The FDA lists U.S. contact options at Recalls@teleflex.com and 1-866-396-2111 for questions, quality problems or adverse reactions.
Health care professionals and consumers can report adverse reactions or quality problems through the FDA’s MedWatch program. The agency says it will update its Early Alert page if significant information emerges. The available notice does not set a public deadline for returns or state when the FDA’s review will conclude.
Key Questions
Which products are affected?
The FDA lists Arrow-marked hydrophilic-coated nitinol and stainless-steel guidewires, along with specified pressure-injectable PICC and JACC products and certain kits containing Spring Wire Guide components. Check the full FDA product list and company notice for the exact configurations.
What should a facility do with affected devices?
Arrow’s customer letter recommends that facilities stop use and distribution, quarantine affected stock, contact Teleflex Customer Service to arrange returns, and provide the notice to customers who received impacted products.
What is the reported device issue?
Arrow said the hydrophilic coating on supplied Spring Wire Guide components may swell inconsistently in saline, clump and potentially detach. The FDA says detached particles could enter the bloodstream; the notice describes this as a potential risk.
Have serious injuries or deaths been reported?
The FDA says Arrow International reported no serious injuries or deaths as of Nov. 5, 2026. The notice does not provide a full account of any less serious reports or establish that the potential failure occurred in every affected device.
Where can customers ask questions or report a problem?
U.S. customers can contact Arrow International at Recalls@teleflex.com or 1-866-396-2111. Adverse reactions and device quality problems can also be reported to the FDA through MedWatch.
Source: fda.gov
