{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "164298", "product_res_number": "Z-1903-2018", "event_date_initiated": "2018-05-02", "event_date_posted": "2018-05-21", "recall_status": "Open, Classified", "res_event_number": "80056", "product_code": "DSQ", "pma_numbers": [ "P100047" ], "product_description": "Heartware Medtronic HVAD System for cardiac use. Including the following parts:\n(a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420\n(b) DC Adapter, Product numbers: 1435, 1440\n(c) AC Adapter, Product numbers: 1425, 1430\n(d) Battery Pack, Product number: 1650DE\n\n\nIndication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.", "code_info": "ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376", "firm_fei_number": "3007042319", "recalling_firm": "Heartware", "address_1": "14400 NW 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2807", "additional_info_contact": "877-367-4823", "reason_for_recall": "Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.", "root_cause_description": "Device Design", "action": "The firm notified physicians and healthcare professionals about the device correction by letter on 05/02/2018. The letter explained problem and provided recommendations for effective power source management of the system.\n\nMedtronic began notifying VAD Clinicians in the US on May 31, 2018, mainly via 2-day courier, and OUS via locally approved methods, of a newly available field service. A field service for application of a lubricant to the HVAD System power source connectors to mitigate the potential for transient interruptions of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller is now available.", "product_quantity": "175878 devices", "distribution_pattern": "Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.", "openfda": { "device_name": "Ventricular (Assist) Bypass", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P920014", "P980012", "P160054", "P160035", "P900023", "P100047", "P170038", "P060040", "P870072" ], "registration_number": [ "2916596", "3008792657", "3004582654", "2133810", "2182208", "3007042319", "1319639", "9612515", "3008454189", "2134470", "3005228872", "2029275", "3003306248", "1218444", "1927395", "1721676", "3019807891", "2031044", "3010163695", "2528981", "3011823740", "3012931014", "3002807090" ], "fei_number": [ "2916596", "3008792657", "1000306431", "3004582654", "3006003617", "2182208", "3007042319", "3008454189", "3005228872", "3002462840", "1000138054", "3003306248", "1218444", "1927395", "1721676", "3001236763", "3019807891", "3002808437", "3010163695", "2528981", "3011823740", "3000203066", "3012931014" ] } } ] }