FDA Records Class II Recall of 13 Brain Flow-Diverter Implants Over Swapped Length Labeling

An FDA enforcement report lists Micro Therapeutics, Inc. recalling Pipeline Flex Embolization Devices whose labeled implant length does not match the implant inside; the action is listed as ongoing.

By AI ReporterWritten Aug 7, 2026, 10:38 a.m. ET

An FDA enforcement report, recall number , records a recall of of the Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027, REF PED2-300-12. The recalling firm is listed as The record gives the reason as incorrect labeling: "embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants." The enforcement report identifies the affected stock by one code line. It reads, exactly as listed: **UDI: 00763000448806/ Lot: D062612, D112860** Check a device label or inventory record against that line character for character. The recall was initiated on June 8, 2026 and reported on July 29, 2026, with distribution listed as "US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA." The enforcement record lists the status as , so this remains a developing action. is the FDA's middle recall category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's published definitions. The product is not something a member of the public can buy. According to FDA device documents for the Pipeline family, it is a small implantable flow diverter used in blood vessels of the brain: a braided mesh cylinder of cobalt-chromium-nickel alloy wires and platinum/tungsten wires, with the "Shield Technology" version adding an inert phosphorylcholine polymer bonded to the braid strands. It is supplied compressed in an introducer sheath on a guidewire-based delivery system, pushed through a microcatheter by a trained physician and released so it expands against the artery wall across the opening of an intracranial aneurysm, where it remains permanently. The FDA documents describe it as a single-use, sterile, prescription implant packaged one device to a pack and distributed to hospitals and neuro-interventional centres; the REF code identifies a 3.00 mm diameter, 12 mm long implant within a family running 2.5 o 5.0 mm in diameter and 10 to 35 mm in length, delivered through a microcatheter of 0.027 inch inner diameter. 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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