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Heartware, Inc.

Company FL
Found in 2 federal databases · 65 total records
fda 64 records
FDA Device Recall: PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 2023-12-13
Class II — Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm ma...
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FDA Device Recall: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, 2023-12-13
Class II — Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm ma...
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FDA Device Recall: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Nu 2023-12-13
Class II — Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm ma...
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FDA Device Recall: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 110 2023-12-13
Class II — Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm ma...
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FDA Device Recall: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1 2023-12-13
Class II — Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm ma...
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FDA Device Recall: HeartWare Model 1100 2022-12-28
Class II — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline conn...
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FDA Device Recall: HeartWare HVAD Pump Kit, REF 1104CA-CLIN 2022-12-28
Class II — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline conn...
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FDA Device Recall: HeartWare Model 1101 2022-12-28
Class II — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline conn...
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FDA Device Recall: HeartWare HVAD Pump Kit, REF 1103 2022-12-28
Class II — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline conn...
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FDA Device Recall: HeartWare HVAD Pump Kit, REF 1104 2022-12-28
Class II — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline conn...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650 2022-08-24
Class I — Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to re...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407D 2022-05-25
Class II — Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular A...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 2022-05-25
Class II — Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular A...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 2022-05-25
Class II — Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular A...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420- 2022-05-25
Class II — Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular A...
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FDA Device Recall: HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ 2022-05-25
Class II — Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular A...
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FDA Recall: Heartware, Inc. — Class I 20210818
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher fre | Product: HeartWare HVAD Pump Implant Kit, REF 1...
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FDA Recall: Heartware, Inc. — Class I 20210818
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher fre | Product: HeartWare HVAD Pump Implant Kit, REF 1...
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FDA Recall: Heartware, Inc. — Class II 20210428
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified beh | Product: Instructions for Use and Patient Manua...
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FDA Recall: Heartware, Inc. — Class II 20210428
IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms | Product: Instructions for Use and Patient Manua...
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FDA Recall: Heartware, Inc. — Class I 20210414
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables | Product: Medtronic HVAD Controller, Product Num...
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FDA Device Recall: Medtronic HVAD Pump Implant Kits 2021-09-22
Class II — There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. Th...
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FDA Device Recall: HeartWare HVAD Pump Implant Kit, REF 1125 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Pump Implant Kit, REF 1153 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Outflow Graft, REF MCS1725OG 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Pump Accessories, REF MCS1753AK 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Driveline Extension Cable, REF 100 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Pump Implant Kit, REF 1103 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Pump Implant Kit, REF 1104 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare HVAD Implant Kit, REF 1104JP 2021-08-18
Class I — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events an...
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FDA Device Recall: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for h 2021-07-21
Class II — The pump has an impeller with a shroud height that did not meet the lower control limit.
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FDA Device Recall: Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies 2021-04-28
Class II — IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the ...
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FDA Device Recall: Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies t 2021-04-28
Class II — IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period ...
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FDA Device Recall: Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Medtronic HVAD Monitor Data Cable, Product Number: 1575 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Medtronic HVAD Alarm Adapter, Product Number: 1450 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1 2021-04-14
Class I — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller p...
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FDA Device Recall: Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c 2021-02-10
Class I — Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restar...
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FDA Recall: Heartware, Inc. — Class I 20200603
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. | Product: Heartware HVAD Pump Implant Kit, Produc...
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FDA Device Recall: Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 2020-06-03
Class I — The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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FDA Device Recall: Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 2020-06-03
Class I — The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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FDA Device Recall: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 2020-06-03
Class I — The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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FDA Device Recall: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP 2020-06-03
Class I — The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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FDA Device Recall: HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated 2020-03-18
Class I — Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
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FDA Device Recall: HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is 2020-03-18
Class I — Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
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FDA Device Recall: Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US 2018-12-19
Class II — HVAD Battery Charger units manufactured with wrong inductors.
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FDA Device Recall: Heartware Medtronic HVAD System for cardiac use. Including the following parts 2018-06-06
Class I — 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 m...
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FDA Recall: Heartware — Class I 20170503
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now inten | Product: HeartWare Ventricular Assist System (H...
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product 2017-05-03
Class I — In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to ...
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FDA Device Recall: HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS 2017-05-03
Class I — Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
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FDA Device Recall: HeartWare Ventricular Assist System Controller Product Usage: For use as a 2016-10-26
Class I — Loose connector ports in controller body.
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FDA Device Recall: HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx 2016-07-20
Class I — Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac trans 2015-07-08
Class II — Complaints with the HVAD Abnormal Power Source Switching.
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / O 2015-06-24
Class I — Complaints with the HVAD Internal Controller Alarm Battery failures.
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transp 2015-06-17
Class II — Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 2015-06-17
Class I — Complaints with the HVAD Retraction of Pins within the driveline connector.
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FDA Device Recall: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS 2015-06-17
Class I — HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
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FDA Device Recall: HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: Fo 2015-03-04
Class I — The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
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FDA Device Recall: HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWar 2014-05-21
Class II — Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
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FDA Device Recall: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog 2014-04-30
Class I — The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
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FDA Device Recall: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) 2013-08-07
Class II — Potential to electrostatic discharged (ESD)
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FDA Device Recall: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) 2013-05-22
Class II — HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
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ny_corps 1 records
NY Corp: HEARTWARE INC. 2019-10-03
DOMESTIC NOT-FOR-PROFIT CORPORATION | County: Nassau | Jurisdiction: New York
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C.F.A.I. aggregates publicly available federal records for informational purposes only. Nothing on this site constitutes legal, financial, or professional advice. No claims are made regarding the accuracy or completeness of any data presented.