Company · US

Heartware, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 1997. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)

75recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DSQ	Ventricular (Assist) Bypass	75
IZI	System, X-Ray, Angiographic	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 16, 1997	K972229	IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM Heartware, Inc.	IZI

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Dec 2, 2023	Heartware, Inc. PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 Open, Classified	DSQ	None listed
Dec 2, 2023	Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 Open, Classified	DSQ	None listed
Jun 22, 2023	Heartware, Inc. 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 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF MCS1705PU Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF 1205 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104JP Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104CA-CLIN Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare HVAD Pump Kit, REF 1103 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare Model 1102 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare Model 1101 Open, Classified	DSQ	None listed
Dec 21, 2022	Heartware, Inc. HeartWare Model 1100 Open, Classified	DSQ	None listed
Aug 18, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Re Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit Open, Classified	DSQ	None listed
Mar 30, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 Open, Classified	DSQ	None listed
Jan 27, 2022	Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Open, Classified	DSQ	None listed
Aug 6, 2021	Heartware, Inc. Medtronic HVAD Pump Implant Kits Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Pump Accessories, REF MCS1753AK Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Outflow Graft, REF MCS1725OG Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Implant Kit, REF MCS1705PU Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Implant Kit, REF 1104JP Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Driveline Extension Cable, REF 100US Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Driveline Extension Cable, REF 100 Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Pump Implant Kit, REF 1153 Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Pump Implant Kit, REF 1125 Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Pump Implant Kit, REF 1104 Open, Classified	DSQ	None listed
Jun 3, 2021	Heartware, Inc. HeartWare HVAD Pump Implant Kit, REF 1103 Open, Classified	DSQ	None listed
May 28, 2021	Heartware, Inc. 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 T Terminated	DSQ	None listed
Feb 26, 2021	Heartware, Inc. 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. Hear Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. 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. Hear Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. 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 Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. Medtronic HVAD Monitor Data Cable, Product Number: 1575 Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. Medtronic HVAD Alarm Adapter, Product Number: 1450 Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT Open, Classified	DSQ	None listed
Feb 26, 2021	Heartware, Inc. 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, 14 Open, Classified	DSQ	None listed
Feb 4, 2021	Heartware, Inc. 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 Open, Classified	DSQ	None listed
Apr 3, 2020	Heartware, Inc. Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 Open, Classified	DSQ	None listed

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