{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216563", "product_res_number": "Z-0508-2026", "event_date_initiated": "2025-10-09", "event_date_posted": "2025-11-14", "recall_status": "Open, Classified", "res_event_number": "97782", "product_code": "DSQ", "pma_numbers": [ "P060040" ], "product_description": "Brand Name: HeartMate\nProduct Name: HeartMate II Controller (standalone)\nModel/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, US; 107801, HeartMate II Pocket Controller\nSoftware Version: N/A\nProduct Description: The HeartMate II System Controller is a small computer that controls and monitors system\noperation. It sends power and operating signals to the Left Ventricular Assist Device and\nadjusts device operation to maintain programmed levels of cardiac support. The System\nController identifies alarm conditions and initiates Hazard and Advisory alarms. It records\ndevice performance and alarm data, and transfers the information to the HeartMate Touch\nCommunication System.\nComponent: Yes, HeartMate II LVAS Implant Kit", "code_info": "Lot Code: All units of the following models are impacted:\nModel 106017 UDI: 00813024011248\nModel 106762 UDI: 00813024011286\nModel 107801 UDI: 00813024011996\n\nNote: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.", "firm_fei_number": "2916596", "recalling_firm": "Thoratec LLC", "address_1": "6035 Stoneridge Dr", "city": "Pleasanton", "state": "CA", "postal_code": "94588-3270", "additional_info_contact": "Ms. Shelley Lange\n1-612-3463514", "reason_for_recall": "Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.", "root_cause_description": "Device Design", "action": "On 10/09/2025, the firm sent via email an \"URGENT MEDICAL DEVICE RECALL (CORRECTION)\" Letter to customers informing them that Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. The issue is potentially due to excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller which results in corrosion of the ribbon cable connectors.\n\nWhat Customers should know:\nWhen the Backup Battery Fault Alarm is active, this Advisory alarm will appear as a flashing yellow wrench on the user interface and Call Hospital Contact; Backup Battery Fault will appear on the screen, accompanied by a slow beep tone. When in a clinical setting, the HeartMate Touch App will have an active alarm that reads Replace Backup Battery. \nAs a reminder, when this alarm is active and the pump is running and flow is maintained (indicated by the green arrow symbol ), this alarm does not affect the controller or pump functionality.\n\nCustomers are instructed:\n-When performing Backup Battery installation or replacement, clinicians should minimize excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller. An example of excessive handling would be using the ribbon cable to hold the weight of the controller.\n-Remind patients and caregivers to follow the Patient Handbook: If System Controller Backup Battery Fault Alarm is active, patients should first ensure that no other alarms are active, and then they should call their hospital contact as soon as possible for diagnosis and instructions. Patients and caregivers should not immediately attempt to exchange the System Controller without clinical guidance.\n\nFor questions or further assistance is needed regarding the Backup Battery Alarm after following Instructions for Use, contact Abbott Technical Service at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).", "product_quantity": "2424", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.", "openfda": { "device_name": "Ventricular (Assist) Bypass", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P870072", "P900023", "P170038", "P100047", "P980012", "P060040", "P160035", "P160054", "P920014" ], "registration_number": [ "3003306248", "2133810", "3008792657", "3004582654", "3019807891", "1218444", "3012931014", "2029275", "3008454189", "1927395", "2031044", "3005228872", "3002807090", "3007042319", "2182208", "1721676", "2528981", "2134470", "1319639", "3011823740", "3010163695", "9612515", "2916596" ], "fei_number": [ "3003306248", "3008792657", "3004582654", "3019807891", "1218444", "3012931014", "3008454189", "1927395", "1000138054", "3006003617", "1000306431", "3005228872", "3007042319", "2182208", "3002462840", "1721676", "2528981", "3011823740", "3010163695", "3000203066", "3001236763", "2916596", "3002808437" ] } } ] }