{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "199078", "product_res_number": "Z-1379-2023", "event_date_initiated": "2023-02-14", "event_date_posted": "2023-04-12", "recall_status": "Open, Classified", "res_event_number": "91868", "product_code": "DYG", "product_description": "Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)", "code_info": "Primary DI Number: 00690103146554/ Lot: 64191420\t64228620\t64229652\t64238028\t64238630\t64243142\t64243143\t64260684\t64260685\t64262168\t64264946\t64278346\t64289390\t64289391\t64289408\t64304361\t64304362\t64304363\t64314476\t64314477\t64314479\t64320628\t64325327\t64328112\t64328113\t64328114\t64328115\t64337979\t64337980\t64337981\t64345011\t64345012\t64355442\t64362238\t64362239\t64362240\t64362241\t64362242\t64373343\t64373344\t64373345\t64381703\t64383275\t64383276\t64383277\t64385609\t64385610\t64385611\t64385612\t64385613\t64398982\t64398983\t64398984\t64410910\t64410911\t64410912\t64410913\t64410914\t64423626\t64423627\t64423628\t64423629\t64423630\t64430338\t64430339\t64430340\t64446892\t64446893\t64446894\t64446895\t64458777\t64458778\t64458779\t64462548\t64462549\t64470780\t64470781\t64470782\t64470783\t64478098\t64478099\t64483100\t64483101\t64483102\t64483103\t64483104\t64496490\t64496491\t64514042\t64540629\t64540630\t64540631\t64552372\t64577637\t64578749\t64578750\t64584948\t64584949\t64584950\t64584951\t64584952\t64603534\t64609691\t64613340\t64617864\t64623071\t64636398\t64664097\t64664390\t64742870\t64746321\t64746322\t64762706\t64769085", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "linnette_torres@edwards.com\n949-756-4582", "reason_for_recall": "There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.", "root_cause_description": "Packaging process control", "action": "On March 10, 2023, Edwards issued a \"Urgent Medical Device Correction\" notification to affected consignees. In addition to informing consignees about the correction, Edwards ask consignees to take the following actions: \n\nActions to be taken by customer\n1. Review the customer letter for advice on action to be taken.\n2. Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process.\n3. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred.\n4. Please post a copy of this notice near and/or with affected devices.\n5. Verify your inventory on the attached acknowledgement form.\n6. Contact Edwards Customer Service at 1-888-352-0904 for a Return Goods Authorization (RGA) if you would like an exchange of your device or to request a biokit if returning used devices.\n\nActions to be taken by distributors: \n\n1. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Customer Service for instructions for handling product still within your control.\n\n2. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to US.FCA@edwards.com. If you have any questions, please contact Edwards Customer Service at: 1-888-352-0904.\n\nAdverse Event Reporting in the US:\n1. Please contact the FDA s MedWatch Adverse Event reporting program either online, by regular mail, or by fax: Complete and submit the report Onl", "product_quantity": "59,094 units", "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tWA\tWI\tWV\tWY\nOUS: None", "openfda": { "k_number": [ "K822034", "K874117", "K935404", "K940795", "K771306", "K940547", "K832324", "K963336", "K160084", "K820883", "K821057", "K823007", "K833918", "K094048", "K812111", "K801865", "K010253", "K893474", "K904287", "K782071", "K193466", "K831185", "K901247", "K963248", "K802288", "K934742", "K081052", "K862119", "K925444", "K822806", "K883948", "K003118", "K233983", "K820229", "K760533", "K820702", "K834036", "K951566", "K874465", "K841705", "K771823", "K821996", "K812563", "K851948", "K961999", "K012225", "K896466", "K852294", "K893435", "K810124", "K955816", "K901287", "K811276", "K872770", "K822350", "K911840", "K834037", "K802481", "K920869", "K830604", "K812324", "K831854", "K841639", "K233824", "K823484", "K231248", "K841251", "K770522", "K821004", "K813578", "K772059", "K832380", "K832957", "K841640", "K853383", "K820222", "K833572", "K810352", "K821099", "K843411", "K001063", "K821235", "K993245", "K843409", "K831945", "K833836", "K242451", "K222117", "K832287", "K822723", "K802338", "K841876", "K841317", "K892530", "K823433", "K900879", "K850952", "K771043", "K924452" ], "pma_number": [ "P810046" ], "registration_number": [ "9680794", "2024168", "1317547", "3002807314", "1625425", "3015859709", "3006082230", "9673241", "1061927", "1220948", "1319639", "3004784537", "1061124", "9680260", "1000563940", "3013162291", "9615817", "2025816", "3013300026", "2649622", "3040153768", "3010532612", "3013764800", "3032916632", "3004091615", "2939561", "8043983", "3038791046", "3045042524", "2011171", "1035166", "3045891669", "3005718570", "3013319212", "1720929", "2133641", "1713468", "3017060084", "2024311", "1018233", "1721676", "2182208", "2521402", "2523676", "3006425876", "3008496528", "2648045", "3004111573", "3004832480", "3014656749" ], "fei_number": [ "2024168", "1317547", "1000512168", "3002807314", "1625425", "3015859709", "3016261803", "3006082230", "1220948", "3003248396", "3004784537", "1000563940", "3000203466", "3013162291", "2025816", "3013300026", "2649622", "3040153768", "3004635528", "3010532612", "3013764800", "3032916632", "3004091615", "3038791046", "3045042524", "2011171", "1000138054", "1035166", "3045891669", "3005718570", "3013319212", "1720929", "3003081151", "1713468", "3002315844", "3000203000", "3017060084", "2024311", "1018233", "1721676", "2182208", "2521402", "2523676", "3006425876", "3008496528", "2648045", "3004111573", "3004832480", "3003737899", "3014656749" ], "device_name": "Catheter, Flow Directed", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1240", "device_class": "2" } } ] }