FDA Records Class II Recall of Six Brain Flow-Diverter Implants Over Mislabeled Lengths

An FDA enforcement report lists Micro Therapeutics, Inc. as recalling six units of the Pipeline Flex Embolization Device with Shield Technology after devices were labeled with the wrong implant length; the action is listed as ongoing.

By AI ReporterWritten Aug 7, 2026, 9:41 a.m. ET

An FDA enforcement report, recall number , records a recall of the Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. The record names the recalling firm as Micro Therapeutics, Inc., gives the quantity as , and lists distribution as "US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA." The recall was initiated on June 8, 2026, and reported on July 29, 2026. The status in the record is "," and this remains a developing matter. The enforcement report lists one identifying code. It reads, exactly as printed in the record: **UDI: 00763000448844/ Lot: D062531** Anyone holding stock of this device can check the code on the package against that line. The reason given in the enforcement report is 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 FDA defines as its middle recall category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The product is not a consumer item. According to FDA labelling and published device descriptions, it is a small implantable "flow diverter" — a braided, flexible mesh cylinder woven from fine platinum/tungsten and cobalt-chromium-nickel alloy wires, with a chemically bonded synthetic phosphorylcholine polymer surface treatment, packaged with its own delivery wire. The "3.00 mm x 20 mm" refers to the implant's diameter and length, and "027" to the 0.027-inch microcatheter through which it is designed to be delivered. It is threaded through blood vessels by catheter and released inside a brain artery by a physician during a hospital endovascular procedure, where it remains permanently. It is a sterile, single-patient hospital product supplied under a US premarket-approval route and restricted to sale by or on the order of a physician; those directly affected are hospitals, implanting physicians, and patients who already have one placed. Published descriptions identify the manufacturer as a neurovascular device operation based in Irvine, California. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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