{ "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": "50332", "product_res_number": "Z-0577-2007", "event_date_initiated": "2007-02-09", "event_date_posted": "2007-03-08", "recall_status": "Terminated", "event_date_terminated": "2008-05-07", "res_event_number": "37314", "product_code": "KRA", "k_numbers": [ "K060422" ], "product_description": "EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA\n\nPackaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. \n\nEndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; \n\nLysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150", "code_info": "All Models with Serial Number greater than and equal to 0610XXXX-XXX", "firm_fei_number": "3001627457", "recalling_firm": "Ekos Corp", "address_1": "11911 N Creek Parkway South", "city": "Bothell", "state": "WA", "postal_code": "98011", "additional_info_contact": "Jocelyn Kersten\n425-415-3132", "reason_for_recall": "Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.", "root_cause_description": "Other", "action": "On 2/9/07 the firm faxed and sent via certified return receipt an URGENT: Device Recall letter to their consignees. The letters requested to immediately examine stock and segregate all recalled products. In addition, the firm''s representatives will contact, via phone or visit, each of the consignees. Product is to be returned to the firm.", "product_quantity": "446 distributed", "distribution_pattern": "Nationwide.", "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", "K033913", "K042187", "K250794", "K000177", "K052738", "K212719", "K030688", "K231148", "K874242", "K060224", "K243534", "K202318", "K955525", "K161801", "K131772", "K152625", "K050205", "K071468", "K210339", "K163701", "K160884", "K223139", "K962129", "K020680", "K171665", "K980104", "K070384", "K182071", 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"3017823876", "3003807466", "3014590708", "3014787927", "3015151147" ], "device_name": "Catheter, Continuous Flush", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1210", "device_class": "2" } } ] }