|
Device |
ventricular (assist) bypass |
Definition |
Approved pma: P870072 |
Product Code | DSQ |
Device Class |
3
|
Premarket Approvals (PMA) |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
2018 |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
9
|
12
|
4
|
20
|
36
|
30
|
24
|
37
|
36
|
35
|
34
|
48
|
38
|
33
|
48
|
42
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott |
I |
May-17-2018 |
2 |
Abiomed, Inc. |
I |
Mar-04-2010 |
3 |
Abiomed, Inc. |
II |
Sep-16-2009 |
4 |
Abiomed, Inc. |
II |
Sep-01-2009 |
5 |
BERLIN HEART GMBH |
I |
May-25-2023 |
6 |
Datascope Corporation |
II |
Oct-24-2022 |
7 |
HeartWare Inc |
II |
Jun-26-2015 |
8 |
HeartWare Inc |
I |
Jun-13-2015 |
9 |
HeartWare Inc |
I |
Jun-11-2015 |
10 |
HeartWare Inc |
II |
Jun-10-2015 |
11 |
HeartWare Inc |
I |
Jun-08-2015 |
12 |
HeartWare Inc |
I |
May-14-2015 |
13 |
HeartWare Inc |
I |
Feb-25-2015 |
14 |
HeartWare Inc |
II |
May-14-2014 |
15 |
HeartWare Inc |
I |
Apr-23-2014 |
16 |
HeartWare Inc |
II |
Jul-29-2013 |
17 |
HeartWare, Inc |
I |
Oct-13-2016 |
18 |
Heartware |
I |
May-21-2018 |
19 |
Heartware |
I |
Apr-27-2017 |
20 |
Heartware |
I |
Apr-25-2017 |
21 |
Heartware Inc |
II |
May-14-2013 |
22 |
Heartware, Inc. |
II |
Dec-02-2023 |
23 |
Heartware, Inc. |
II |
Jun-22-2023 |
24 |
Heartware, Inc. |
II |
Dec-21-2022 |
25 |
Heartware, Inc. |
I |
Aug-18-2022 |
26 |
Heartware, Inc. |
II |
May-17-2022 |
27 |
Heartware, Inc. |
II |
Mar-04-2022 |
28 |
Heartware, Inc. |
II |
Sep-16-2021 |
29 |
Heartware, Inc. |
I |
Aug-06-2021 |
30 |
Heartware, Inc. |
II |
Jul-13-2021 |
31 |
Heartware, Inc. |
II |
Apr-21-2021 |
32 |
Heartware, Inc. |
II |
Apr-20-2021 |
33 |
Heartware, Inc. |
I |
Apr-16-2021 |
34 |
Heartware, Inc. |
I |
Apr-06-2021 |
35 |
Heartware, Inc. |
I |
May-22-2020 |
36 |
Heartware, Inc. |
I |
Mar-09-2020 |
37 |
Heartware, Inc. |
II |
Dec-07-2018 |
38 |
Heartware, Inc. |
II |
Oct-03-2018 |
39 |
Heartware, Inc. |
I |
Oct-17-2016 |
40 |
Heartware, Inc. |
I |
Jul-08-2016 |
41 |
Jarvik Heart Inc |
II |
Dec-18-2018 |
42 |
Medtronic Inc |
I |
Jun-21-2022 |
43 |
Medtronic Inc |
I |
Jun-03-2022 |
44 |
Medtronic Inc |
II |
May-17-2022 |
45 |
Medtronic Inc |
I |
Feb-04-2021 |
46 |
Thoratec Corp |
II |
Nov-24-2009 |
47 |
Thoratec Corp |
II |
Oct-13-2010 |
48 |
Thoratec Corp. |
I |
Jun-07-2024 |
49 |
Thoratec Corp. |
I |
May-01-2024 |
50 |
Thoratec Corp. |
I |
Mar-22-2024 |
51 |
Thoratec Corp. |
I |
Feb-02-2024 |
52 |
Thoratec Corp. |
II |
Sep-29-2023 |
53 |
Thoratec Corp. |
II |
Nov-26-2021 |
54 |
Thoratec Corp. |
II |
Dec-27-2019 |
55 |
Thoratec Corp. |
II |
Aug-22-2019 |
56 |
Thoratec Corp. |
II |
Apr-19-2019 |
57 |
Thoratec Corporation |
I |
May-24-2017 |
58 |
Thoratec Corporation |
I |
Mar-21-2014 |
59 |
Thoratec Corporation |
I |
Mar-23-2012 |
60 |
Thoratec LLC |
II |
Aug-13-2024 |
61 |
Thoratec Switzerland GMBH |
II |
Jun-27-2024 |
|
|
|
|