{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "195143", "product_res_number": "Z-1556-2022", "event_date_initiated": "2022-06-30", "event_date_created": "2022-08-18", "recall_status": "Open, Classified", "res_event_number": "90622", "product_code": "KRA", "k_numbers": [ "K030688", "K093750" ], "product_description": "Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only", "code_info": "Lot # B177543 UDI: (00) 847536006270", "firm_fei_number": "3004904811", "recalling_firm": "Micro Therapeutics, Inc.", "address_1": "9775 Toledo Way", "city": "Irvine", "state": "CA", "postal_code": "92618-1811", "additional_info_contact": "Kelli Lynch\n203-500-3328", "reason_for_recall": "Outer carton packaging of microcatheters were exposed to wet substance during transport.", "root_cause_description": "Under Investigation by firm", "action": "On June 30, 2022, Micro Therapeutics, Inc. issued a \"URGENT: MEDICAL DEVICE RECALL (REMOVAL)\" to affected customers. The recall notification ask consignees to take the following actions: \n\n1.\tDo NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory. \n\n2.\tReturn the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product.\n \n3.\tComplete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. \n\n4. This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. \n\n5. Adverse reactions or quality problems experienced with this product should be reported to Medtronic and FDA MedWatch Adverse Event Reporting program via:\n \n\"\tMedtronic Quality Assurance at rs.nvcomplaints@medtronic.com or call +1 (763) 514-4000 (Worldwide)\n\"\tThe FDA website (http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm) or call FDA at 1-800-FDA-1088.", "product_quantity": "8 units", "distribution_pattern": "US Nationwide Distribution: None\nOUS: Brazil", "openfda": { "k_number": [ "K231821", "K961668", "K081147", "K180275", "K973645", "K201907", "K971306", "K050205", "K003925", "K945593", "K021591", "K002723", "K122796", "K792141", "K801829", "K000177", "K223176", "K161962", "K994155", "K093750", "K153501", "K093052", "K211110", "K172081", "K993672", "K955534", "K974222", "K091559", "K020733", "K201792", "K053310", "K082163", "K073166", "K260771", "K131772", "K790327", "K113289", "K161402", "K874242", "K032494", "K072724", "K111263", "K062752", "K974473", 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