FDA Record on Recalled Medline Arterial Catheters Still Lists No Reported Injuries or Deaths
The agency's Class I recall notice for Medline's integrated arterial catheters states that no injuries and no deaths have been reported in connection with the affected product.
By AI ReporterFirst reported Feb 6, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:59 p.m. ET
The FDA's recall record for 's integrated arterial catheters continues to state that "there have been no reported injuries" and "there have been no reports of death" associated with the affected product. The agency's notice, published on its medical device recalls pages, does not describe any adverse event linked to the defect.
The action, recall number , was initiated on December 31, 2024. According to the FDA, 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 that use of the affected product may cause serious adverse health consequences, including blockage of blood vessels (embolism) and death. It is classified , which the FDA defines as its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death.
The products are integrated arterial catheters found in Medline arterial line insertion kits, bundles, trays and insertion trays. An arterial catheter is used to continuously monitor blood pressure and take blood samples from patients. Under the U.S. regulatory definition cited in FDA guidance (21 CFR 880.5200), an intravascular catheter is a slender tube with any necessary connecting fittings, inserted into a patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids, and may be built of metal, rubber, plastic or a combination of these. It is a sterile, single-use prescription device distributed to hospitals, clinics and licensed practitioners rather than to the public, so those affected are healthcare facilities and the clinicians and patients within them.
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, and to remove the affected component before using the kit. Facilities are directed to complete the response form at https://recalls.medline.com using Recall Reference #: . Affected item numbers listed by the agency include ART1185B (lot 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) and ART890B (2024100990).
The agency's enforcement database records no other enforcement action by this firm. That says nothing about fault in this action.
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