{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149671", "product_res_number": "Z-0114-2017", "event_date_initiated": "2016-09-23", "event_date_posted": "2016-10-27", "recall_status": "Terminated", "event_date_terminated": "2017-05-01", "res_event_number": "75211", "product_code": "KRA", "k_numbers": [ "K132652" ], "product_description": "VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01\n\nThe VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).", "code_info": "16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701", "firm_fei_number": "3008423090", "recalling_firm": "Sequent Medical Inc", "address_1": "11 Columbia", "city": "Aliso Viejo", "state": "CA", "postal_code": "92656-1460", "additional_info_contact": "949-923-9400", "reason_for_recall": "Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.", "root_cause_description": "Under Investigation by firm", "action": "Sequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to www.customerserviceus@sequentmedical.com. Customers with questions should call (949) 830-9600x130.\nFor questions regarding this recall call 949-923-9400.", "product_quantity": "618 units", "distribution_pattern": "Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,", "openfda": { "k_number": [ "K010004", "K153502", "K082519", "K111490", "K101450", "K964868", "K971306", "K931335", "K993266", "K953133", "K070279", "K040139", "K230636", "K172081", "K214025", "K082613", "K072724", "K180275", "K210114", "K952874", "K951602", "K231279", "K023351", "K003925", "K951502", "K070979", "K801173", "K100892", "K161962", "K860570", "K211525", "K153501", "K132947", "K924661", "K223176", "K885281", "K062752", "K093750", "K142259", "K113773", "K111263", "K034036", "K954020", "K832058", "K914751", "K780479", "K123477", "K161921", "K923368", 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