{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "185158", "product_res_number": "Z-0871-2021", "event_date_initiated": "2020-12-16", "event_date_created": "2021-01-15", "recall_status": "Open, Classified", "res_event_number": "87069", "product_code": "JXG", "k_numbers": [ "K902783" ], "product_description": "REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.", "code_info": "Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029", "firm_fei_number": "3015531529", "recalling_firm": "Medtronic Neurosurgery", "address_1": "5290 California Ave", "city": "Irvine", "state": "CA", "postal_code": "92617-3073", "additional_info_contact": "David Young\n508-452-1644", "reason_for_recall": "Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction", "root_cause_description": "Device Design", "action": "On 12/16/2020, Medtronic sent a \"URGENT: MEDICAL DEVICE RECALL\" notification to affected customers via FedEx. In addition, to notifying consignees about the recall, the firm ask consignees to take the following actions:\n\n1. Identify, segregate, and quarantine affected valves within your inventory.\n2. Contact Medtronic to return affected valves and receive replacement(s). See instructions below.\n3. Please complete and return the customer confirmation form, even if you do not have any affected valves.\n4. Return the form via email to RS.NavFCA@Medtronic.com or via fax to 651-367-7075 within 30 days of receipt.", "product_quantity": "95 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.", "openfda": { "k_number": [ "K161992", "K913412", "K862513", "K905860", "K944595", "K150898", "K182265", "K904120", "K221918", "K914995", "K831396", "K855058", "K811288", "K033698", "K881616", "K981046", "K922936", "K042359", "K781768", "K870660", "K910853", "K760784", "K251598", "K021653", "K841442", "K820311", "K053107", "K980903", "K875205", "K061876", "K093968", "K110751", "K984053", "K823503", "K925810", "K992226", "K002476", "K102589", "K172759", "K172006", "K853366", "K861961", "K030698", "K904883", 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