{ "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": "186062", "product_res_number": "Z-1426-2021", "event_date_initiated": "2021-02-26", "event_date_created": "2021-04-16", "recall_status": "Open, Classified", "res_event_number": "87456", "product_code": "DSQ", "pma_numbers": [ "P100047" ], "product_description": "Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components:\nHVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU\nHVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP\nHVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US\nHVAD DC Adapter Controller: Model Number: 1440\nHVAD DATA CABLE 1575- MONITOR, Model Number: 1575\nHVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE\nHeartWare Patient Pack, Model Number: 1475\nHeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS\nHeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS\n\nThe HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.", "code_info": "All serial numbers", "firm_fei_number": "3007042319", "recalling_firm": "Heartware, Inc.", "address_1": "14400 Nw 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2807", "additional_info_contact": "MCS Customer Service\n877-367-4823", "reason_for_recall": "Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604", "root_cause_description": "Device Design", "action": "The firm, Medtronic, sent an \"Urgent Medical Device Notice\" dated Feb-2021 beginning 26-Feb-2021, UPS 2-day delivery, to its consignees who Medtronic records indicate they have received affected product. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following:\n\" Please review the updated IFU and PM steps as included in Appendix A.2 and share with patients as needed.\n\" This notice must be shared with all those who need to be aware within your organization or to any organization where potentially affected patients have been transferred.\n\" Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com.\n\nIf you have questions regarding this material, please contact your Medtronic Field Representative or Sr. Customer Quality Director, at 763-526-8583, email: rs.cvgrecalls@medtronic.com or Customer Quality at megan.e.ties@medtronic.com.", "product_quantity": "23123 devices (11292 US)", "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: ARGENTINA, Armenia, Australia, AUSTRIA, Bahrain, BELGIUM, Brazil, CANADA, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, FINLAND, France, GERMANY, Greece, Hong Kong, Hungary, INDIA, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Latvia, LEBANON, LITHUANIA, Luxembourg, Macedonia, Malaysia, NETHERLANDS, NEW ZEALAND, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA\nSpain, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab, Emirates, United Kingdom, 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" ] } } ] }