Atlas FDA

Heartware, Inc.

36 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Heartware, Inc.

RecordFirmDate
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 recall (Z-0475-2024)Heartware, Inc.2023-12-02
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 recall (Z-0476-2024)Heartware, Inc.2023-12-02
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 recall (Z-0477-2024)Heartware, Inc.2023-12-02
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 recall (Z-0478-2024)Heartware, Inc.2023-12-02
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 recall (Z-0479-2024)Heartware, Inc.2023-12-02
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN recall (Z-0480-2024)Heartware, Inc.2023-12-02
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104J recall (Z-0481-2024)Heartware, Inc.2023-12-02
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Numb recall (Z-0482-2024)Heartware, Inc.2023-12-02
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS recall (Z-0483-2024)Heartware, Inc.2023-12-02
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 152 recall (Z-1993-2023)Heartware, Inc.2023-06-22
HeartWare Model 1100 recall (Z-0742-2023)Heartware, Inc.2022-12-21
HeartWare Model 1101 recall (Z-0743-2023)Heartware, Inc.2022-12-21
HeartWare Model 1102 recall (Z-0744-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF 1103 recall (Z-0745-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF 1104 recall (Z-0746-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF 1104CA-CLIN recall (Z-0747-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF 1104JP recall (Z-0748-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF 1205 recall (Z-0749-2023)Heartware, Inc.2022-12-21
HeartWare HVAD Pump Kit, REF MCS1705PU recall (Z-0750-2023)Heartware, Inc.2022-12-21
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE recall (Z-1512-2022)Heartware, Inc.2022-08-18
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, recall (Z-0946-2021)Heartware, Inc.2021-02-04
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynam recall (Z-1427-2020)Heartware, Inc.2020-03-09
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated fo recall (Z-1428-2020)Heartware, Inc.2020-03-09
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardi recall (Z-0005-2017)Heartware, Inc.2016-10-17
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Cata recall (Z-1887-2016)Heartware, Inc.2016-07-08
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation recall (Z-1917-2015)HeartWare Inc2015-06-26
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101 recall (Z-1731-2015)HeartWare Inc2015-06-13
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, recall (Z-1726-2015)HeartWare Inc2015-06-11
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation recall (Z-1751-2015)HeartWare Inc2015-06-10
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 110 recall (Z-1698-2015)HeartWare Inc2015-06-08
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is int recall (Z-1604-2015)HeartWare Inc2015-05-14
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bri recall (Z-1131-2015)HeartWare Inc2015-02-25
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery recall (Z-1607-2014)HeartWare Inc2014-05-14
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 110 recall (Z-1471-2014)HeartWare Inc2014-04-23
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) recall (Z-1813-2013)HeartWare Inc2013-07-29
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) recall (Z-1323-2013)Heartware Inc2013-05-14

Track Heartware, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.