{ "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": "159486", "product_res_number": "Z-0537-2018", "event_date_initiated": "2017-09-21", "event_date_posted": "2018-02-06", "recall_status": "Terminated", "event_date_terminated": "2020-03-20", "res_event_number": "78406", "product_code": "LKK", "pma_numbers": [ "P860004" ], "product_description": "Medtronic Ascenda(R) Intrathecal Catheter, Models:\n(a) 8780, UDI: 00643169202122, 00643169783027\n(b) 8781, UDI: 00643169202139\n(c) 8784, UDI: 00643169202153\n\nThe Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.", "code_info": "(a) Model 8780: N740471001, N740482002, N740507001, N741669001, N741918005, N742124002, N742180002, N742214002, N743749002, N747547001, N740471002, N740482003, N740507002, N741669002, N742077001, N742124004, N742180003, N742214003, N743749004, N747547003, N740471003, N740482004, N740507003, N741669003, N742077002, N742124005, N742180004, N742214004, N743749005, N747547004, N740471004, N740482005, N740507004, N741669004, N742077003, N742124006, N742180006, N742214005, N743749006, N747547005, N740471005, N740482006, N740507005, N741669005, N742077004, N742143001, N742184003, N742942001, N743773001, N740471006, N740496001, N740507006, N741669006, N742077005, N742143002, N742184004, N742942002, N743773002, N740476001, N740496003, N740508001, N741677001, N742077006, N742143005, N742184005, N742942003, N743773003, N740476002, N740496004, N740508002, N741677002, N742088001, N742143006, N742184006, N742942004, N743773004, N740476004, N740496005, N740508003, N741677004, N742088002, N742151001, N742197001, N742942005, N743773005, N740476006, N740496006, N740508004, \tN741677006, N742088003, N742158002, N742197002, N742977001, N743800006, N740477001, N740500001, N740508006, N741688001, N742088004, N742158003, N742197003, N742977002, N744024001, N740477002, N740500003, N740511001, N741688002, N742088005, N742158004, N742197004, N742977003, N744024002, N740477003, N740500004, N740511002, N741688003, N742088006, N742158005, N742197005, N742977004, N744024003, N740477004, N740500005, N740511003, N741688004, N742093002, N742158006, N742197006, N742977005, N744024004, N740477005, N740500006, N740511004, N741688005, N742093004, N742172001, N742211001, N743157002, N744024005, N740477006, N740506001, N740511005, N741688006, N742093005, N742172002, N742211002, N743157003, N744024006, N740479003, N740506002, N740540002, N741918001, N742112003, N742172003, N742211003, N743157004, N747546001, N740479004, N740506003, N740540003, N741918002, N742112004, N742172004, N742211004, N743157005, N747546003, N740479005, N740506004, N740540005, N741918003, N742112006, N742172005, N742211005, N743157006, N747546004, N740482001, N740506006, N740540006, N741918004, N742124001, N742180001, N742214001, N743749001, N747546005 \t  (b) Model 8781: N745579001, N745579002, N745579005, N745579006, N746858001  (c) Model 8784: N745557001, N745557002, N745557003, N745557004, N745557005", "firm_fei_number": "2182207", "recalling_firm": "Medtronic Neuromodulation", "address_1": "7000 Central Ave Ne", "city": "Minneapolis", "state": "MN", "postal_code": "55432-3568", "additional_info_contact": "Justin Ihle\n800-707-0933", "reason_for_recall": "There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion\npump.", "root_cause_description": "Other", "action": "Medtronic on September 21, 2017, initiated a medical device recall and sent the following via mail (with delivery confirmation) to the consignees.\n\nIn addition to the mailing, Medtronic field representatives may personally visit the accounts to provide the recall notification, assist the customer as necessary with locating and returning affected product(s), and verify that the customer has or will respond to Medtronic with the Customer Confirmation Form. For further questions, please call (800) 707-0933.", "product_quantity": "194 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "pma_number": [ "P860004", "P140032", "P890055", "P990034", "P800036", "P080012" ], "registration_number": [ "1422634", "3003120897", "3003174284", "1526611", "3018094310", "2032227", "3004209178", "3030198397", "3009183442", "2124215", "2246552", "2523676", "2135338", "3007829657", "3015537318", "2183319", "2182207", "1722746", "3004593495" ], "fei_number": [ "3003120897", "3003174284", "3005700659", "1526611", "3018094310", "3003166194", "3030198397", "3009183442", "1000514656", "2124215", "3004369318", "2246552", "2523676", "1000306216", "3007829657", "3015537318", "2183319", "2182207", "3004593495" ], "device_name": "Pump, Infusion, Implanted, Programmable", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }