Medline Recalls Integrated Arterial Catheters in Class I Action Over Excess Material on Catheter Hub
The FDA says excess material left by a manufacturing issue could detach into the bloodstream; no injuries or deaths have been reported, and the recall remains open.
By AI ReporterFirst reported Feb 6, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:55 p.m. ET
is removing Integrated Arterial Catheters supplied inside arterial line insertion kits, bundles, trays and insertion trays, in an action the U.S. Food and Drug Administration has classified as . The FDA's enforcement record, recall number , gives an initiation date of 31 December 2024. is the FDA's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death, according to the agency's own [recall definitions](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions). The action is still developing.
According to the FDA notice, a manufacturing issue caused excess material to be present on the catheter hub, and that material could detach, potentially entering the body at the insertion place or the bloodstream. The agency states the hazard as serious adverse health consequences including blockage of blood vessels (embolism) and death. The FDA notice says there have been no reported injuries and no reports of death.
The FDA tells users not to use Integrated Arterial Catheters from the affected item numbers and lots, to check stock immediately, to quarantine all affected product, to remove the affected component before using the kit, and to complete the response form at https://recalls.medline.com using Recall Reference #: . The affected item numbers listed are ART1185B/10653160379225, ART255/10653160367598, ART350/10653160362050, ART355/10653160361817, ART475/10653160367659, ART535A/10653160367604, ART545A/10653160375135, ART775C/10653160366102, ART840/10653160366966, ART890B/10653160360834, ART600/10653160312727 and ART690/10653160318019. Lots listed are: ART1185B — 2024102590; ART255 — 2024082690, 2024101590; ART350 — 2024093090; ART355 — 2024081290, 2024112590; ART475 — 2024100790, 2024073090, 2024081590, 2024090990; ART535A — 2024100890, 2024080190; ART545A — 2024102890; ART600 — 2024101090; ART690 — 2024092490; ART775C — 2024083090; ART840 — 2024082390, 2024093090; ART890B — 2024100990.
The FDA describes the product as an arterial catheter used to continuously monitor blood pressure and take blood samples from patients. Background reference material from the National Library of Medicine describes an arterial catheter as a thin, flexible plastic tube, typically single-lumen and a few centimetres long, made of a fluoropolymer such as PTFE or of polyurethane in gauges around 18–24, inserted through the skin into a peripheral artery — most often the radial artery at the wrist, sometimes the femoral or brachial artery — and connected to pressure tubing and a transducer. An "integrated" catheter is built as a single coaxial assembly combining the introducer needle and guidewire in one unit, supplied as one component inside a pre-packaged sterile kit or tray. These are not consumer products: they are single-use devices supplied to hospitals and clinics and placed by trained clinicians in intensive care units, operating rooms and emergency departments, so those affected are hospitals, procurement departments, clinical staff and the patients the kits are used on.
The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.
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