Product code DSQ ยท Class 3
Ventricular (Assist) Bypass
0510(k)s in 12 months (0 all time)
8recalls in 12 months (131 all time)
1recalls that name a 510(k)
Top companies in DSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| HeartWare Inc | 0 | 75 |
| Thoratec Corp | 0 | 42 |
| Abiomed, Inc. | 0 | 5 |
| Medtronic Inc | 0 | 3 |
| BERLIN HEART GMBH | 0 | 2 |
| Abbott | 0 | 1 |
| Datascope Corporation | 0 | 1 |
| Jarvik Heart Inc | 0 | 1 |
| Thoratec Switzerland GMBH | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2022 | Medtronic Inc Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: Open, Classified |
DSQ | None listed |
| Jan 27, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Open, Classified |
DSQ | None listed |
| Oct 22, 2021 | Thoratec Corp. Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU) 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 |
| Apr 3, 2020 | Heartware, Inc. Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 Open, Classified |
DSQ | None listed |
| Apr 3, 2020 | Heartware, Inc. Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP Open, Classified |
DSQ | None listed |
| Apr 3, 2020 | Heartware, Inc. Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 Open, Classified |
DSQ | None listed |
| Apr 3, 2020 | Heartware, Inc. Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 Open, Classified |
DSQ | None listed |
| Mar 9, 2020 | Heartware, Inc. HeartWare HVAD System Battery Charger AC Adapter
The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridg Open, Classified |
DSQ | None listed |
| Mar 9, 2020 | Heartware, Inc. 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 Cardi Open, Classified |
DSQ | None listed |
| Dec 2, 2019 | Thoratec Corp. HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or Terminated |
DSQ | None listed |
| Apr 19, 2019 | Thoratec Corp. Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is inten Terminated |
DSQ | None listed |
| Mar 30, 2019 | Thoratec Corp. Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266 Terminated |
DSQ | None listed |
| Mar 30, 2019 | Thoratec Corp. Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System Terminated |
DSQ | None listed |
| Nov 19, 2018 | Heartware, Inc. 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 Unio Terminated |
DSQ | None listed |
| Oct 15, 2018 | Jarvik Heart Inc Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable Terminated |
DSQ | None listed |
| Aug 28, 2018 | Heartware, Inc. 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 advanc Terminated |
DSQ | None listed |
| May 21, 2018 | Heartware 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, Open, Classified |
DSQ | None listed |
| May 17, 2018 | Abbott Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3
Indicated for providing short-term hemodynamic support in patients with advanced refractory left Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation HeartMate II LVAS with Pocket Controller;
106762 - HMII POCKET CONTROLLER, NA;
UDI: 00813024011286
Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular hea Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation HeartMate II LVAS with Pocket Controller;
106015 - HMII LVAD SEALED KIT-PCTRL, NA
UDI: 00813024011224
Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation HeartMate II LVAS with Pocket Controller;
107801 - HMII PUMP & POCKET CTRL ONLY
UDI:00813024011286
Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular hea Terminated |
DSQ | None listed |
| Mar 10, 2017 | Heartware 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 Open, Classified |
DSQ | None listed |
| Feb 3, 2017 | Heartware 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-stag Open, Classified |
DSQ | None listed |
| Oct 17, 2016 | Heartware, Inc. 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 fai Terminated |
DSQ | None listed |
| Aug 17, 2016 | HeartWare, Inc 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 wh Open, Classified |
DSQ | None listed |
| Jul 8, 2016 | Heartware, Inc. 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 Terminated |
DSQ | None listed |
| Jun 26, 2015 | HeartWare Inc 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. Open, Classified |
DSQ | None listed |
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