{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184990", "product_res_number": "Z-0740-2021", "event_date_initiated": "2020-12-08", "event_date_created": "2020-12-28", "recall_status": "Open, Classified", "res_event_number": "86988", "product_code": "JXG", "k_numbers": [ "K110560" ], "product_description": "Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.", "code_info": "Lot Numbers: 0010038455, 0010258429, 0010289822, 0010316971, 0010376783, 0010061294, 0010258430, 0010289823, 0010316972, 0010384872, 0010061295, 0010258433, 0010297674, 0010316973, 0010384874, 0010083617, 0010265129, 0010297675, 0010336621, 0010384881, 0010083618, 0010265130, 0010297676, 0010336622, 0010384888, 0010083619, 0010265131, 0010297683, 0010336623, 0010393228, 0010083620, 0010265133, 0010305904, 0010353498, EB00006085, 0010083622, 0010265134, 0010305905, 0010353499, EB00006086, 0010083623, 0010265135, 0010305906, 0010369357, EB00006166, 0010097240, 0010278428, 0010305907, 0010369358, EB00007496, 0010097241, 0010278430, 0010305908, 0010369359, EB00007537, 0010097249, 0010281382, 0010305909, 0010376779, EB00009476, 0010097250, 0010281383, 0010316967, 0010376781, 0010097251, 0010289819, 0010316968, 0010376782", "firm_fei_number": "3015531529", "recalling_firm": "Medtronic Neurosurgery", "address_1": "5290 California Ave", "city": "Irvine", "state": "CA", "postal_code": "92617-3073", "reason_for_recall": "There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.", "root_cause_description": "Packaging change control", "action": "On 12/8/2020, Medtronic sent an \"Urgent: Medical Device Recall\" Notification via FedEx to affected consignees. In addition, to providing consignees information on the recall device, Medtronic ask consignees to take the following actions: \n\n1. Identify, segregate, and quarantine affected products within your inventory. The list of affected lots is included.\n2. Contact Medtronic to return affected product and receive replacement(s). See instructions on next page.\n3. Please complete and return the customer confirmation form, even if you do not have any affected product\n4. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via:\n\n- E-mail Medtronic at RS.MNSProdExperienceHelp@Medtronic.com or call 1-877-526-5432.\n Online at the FDA website1 (form available to fax or mail) or call FDA at 1-800-FDA-1088.", "product_quantity": "3,858 units", "distribution_pattern": "Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam", "openfda": { "k_number": [ "K082127", "K864676", "K883114", "K031097", "K030468", "K980778", "K062009", "K871685", "K002476", "K093968", "K222422", "K830894", "K954285", "K820311", "K992465", "K960159", "K904120", "K250636", "K101381", "K024040", "K143111", "K792005", "K021644", "K910853", "K873247", "K251598", "K040943", "K974096", "K823509", "K823503", "K172759", "K902783", "K172537", "K121248", "K981246", "K904883", 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