Data / Medical devices / United States / HeartWare, Inc.
HeartWare, Inc.: FDA-registered device maker in Miami Lakes, FL, United States, 1 PMA approval
HeartWare, Inc. is registered with the FDA (registration 3007042319) in Miami Lakes, FL, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 20, 2012. 35 recall events name it as the recalling firm (19 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007042319
- Address
- 14400 NW 60th Ave, Miami Lakes, FL, United States, 33014
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- September 14, 2016
- Registered through
- 2027
- Brand names listed
- HeartWare Ventricular Assist System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventricular (Assist) Bypass | DSQ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 20, 2012 | P100047 | HEARTWARE VENTRICULAR ASSIST SYSTEM | DSQ | 227 | September 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 31, 2023 | 93405 | Class II | Ongoing | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 | 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 may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | accessdata.fda.gov |
| May 16, 2023 | 92350 | Class II | Ongoing | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal. | accessdata.fda.gov |
| November 29, 2022 | 91281 | Class II | Ongoing | HeartWare Model 1100 | 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 connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the even | accessdata.fda.gov |
| June 28, 2022 | 90593 | Class I | Ongoing | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE | 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 remain charged while discharging. | accessdata.fda.gov |
| March 30, 2022 | 90079 | Class II | Ongoing | HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 | 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 Assist Device (HVAD) system. | accessdata.fda.gov |
| January 27, 2022 | 89559 | Class II | Ongoing | HeartWare Ventricular Assist Device (HVAD) System | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching. | accessdata.fda.gov |
| August 6, 2021 | 88541 | Class II | Ongoing | Medtronic HVAD Pump Implant Kits | 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. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the dri | accessdata.fda.gov |
| June 3, 2021 | 88197 | Class I | Ongoing | HeartWare HVAD Pump Implant Kit, REF 1103 | 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 and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may del | accessdata.fda.gov |
| May 28, 2021 | 88135 | Class II | Terminated | HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT) | The pump has an impeller with a shroud height that did not meet the lower control limit. | accessdata.fda.gov |
| February 26, 2021 | 87604 | Class II | Ongoing | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller k | 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 controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual | accessdata.fda.gov |
| February 26, 2021 | 87603 | Class II | Ongoing | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller k | 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 may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to i | accessdata.fda.gov |
| February 26, 2021 | 87456 | Class I | Ongoing | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, | 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 updat | accessdata.fda.gov |
| February 26, 2021 | 87446 | Class I | Ongoing | Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, | 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 ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port. | accessdata.fda.gov |
| November 19, 2020 | 86924 | Class I | Ongoing | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU | 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 restart attempts at a rate substantially higher than pump in the overall population. | accessdata.fda.gov |
| April 3, 2020 | 85397 | Class I | Ongoing | Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 | 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. | accessdata.fda.gov |
| January 23, 2020 | 84829 | Class I | Ongoing | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BT | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. | accessdata.fda.gov |
| November 19, 2018 | 81609 | Class II | Terminated | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a | HVAD Battery Charger units manufactured with wrong inductors. | accessdata.fda.gov |
| August 28, 2018 | 80966 | Class II | Terminated | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left vent | Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing. | accessdata.fda.gov |
| May 2, 2018 | 80056 | Class I | Ongoing | Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, | 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 betw | accessdata.fda.gov |
| March 10, 2017 | 76807 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the | 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 identified clinicians informing them that a new, improved splice kit is available. | accessdata.fda.gov |
| February 3, 2017 | 76600 | Class I | Ongoing | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular he | Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) | accessdata.fda.gov |
| August 17, 2016 | 74999 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death fr | Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. | accessdata.fda.gov |
| June 8, 2016 | 72001 | Class I | Terminated | HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is desi | Loose connector ports in controller body. | accessdata.fda.gov |
| January 7, 2016 | 73636 | Class I | Terminated | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. | accessdata.fda.gov |
| April 29, 2015 | 71242 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory en | Complaints with the HVAD Retraction of Pins within the driveline connector. | accessdata.fda.gov |
| April 29, 2015 | 71241 | Class II | Ongoing | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. | Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. | accessdata.fda.gov |
| April 29, 2015 | 71240 | Class II | Ongoing | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. | Complaints with the HVAD Abnormal Power Source Switching. | accessdata.fda.gov |
| April 29, 2015 | 71239 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory en | Complaints with the HVAD Internal Controller Alarm Battery failures. | accessdata.fda.gov |
| April 29, 2015 | 71164 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death fro | HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller. | accessdata.fda.gov |
| April 29, 2015 | 71099 | Class I | Ongoing | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the | Failures of the splice repair kit if exposed to excessive force. | accessdata.fda.gov |
| January 16, 2015 | 70340 | Class I | Terminated | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The | The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. | accessdata.fda.gov |
| April 16, 2014 | 67684 | Class II | Terminated | HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart fa | 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. | accessdata.fda.gov |
| December 6, 2013 | 67466 | Class I | Terminated | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refr | The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. | accessdata.fda.gov |
| December 27, 2012 | 64390 | Class II | Terminated | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector. | accessdata.fda.gov |
| May 16, 13 | 65328 | Class II | Terminated | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | Potential to electrostatic discharged (ESD) | accessdata.fda.gov |
Compare with other makers
Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.