Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
104 linked reportsMalfunction 100Death 3Injury 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
10.56
2019-02
0
12.69
2019-03
1
11.63
2019-04
2
12.46
2019-05
1
12.27
2019-06
0
10.34
2019-07
1
11.67
2019-08
3
16.27
2019-09
1
12.2
2019-10
3
13.33
2019-11
4
16.63
2019-12
4
20.13
2020-01
2
14.15
2020-02
0
18.53
2020-03
1
17.04
2020-04
0
19.1
2020-05
1
30.98
2020-06
1
17.15
2020-07
2
24.74
2020-08
2
28.38
2020-09
3
74.85
2020-10
5
99.6
2020-11
7
192.07
2020-12
4
385.31
2021-01
2
264.09
2021-02
2
106.71
2021-03
2
77.38
2021-04
0
78.29
2021-05
3
72.41
2021-06
1
74.45
2021-07
1
89.1
2021-08
0
111.07
2021-09
1
151.73
2021-10
1
318.48
2021-11
1
385.2
2021-12
0
1212.16
2022-01
2
2694.92
2022-02
0
1413.28
2022-03
0
2239.43
2022-04
0
2411.59
2022-05
1
1936.71
2022-06
4
1803.15
2022-07
1
888.18
2022-08
1
227.64
2022-09
0
287.35
2022-10
0
256.49
2022-11
0
245.91
2022-12
1
228.98
2023-01
0
127.34
2023-02
0
255.75
2023-03
0
305.05
2023-04
0
263.63
2023-05
0
240.84
2023-06
2
298.8
2023-07
0
281.34
2023-08
2
268.34
2023-09
1
219.98
2023-10
1
129.77
2023-11
0
130.95
2023-12
1
63.55
2024-01
2
67.35
2024-02
0
101.17
2024-03
1
71.21
2024-04
1
76.75
2024-05
0
46.49
2024-06
0
50.21
2024-07
2
45.53
2024-08
0
41.36
2024-09
0
48.22
2024-10
5
50.88
2024-11
0
57.8
2024-12
0
53.16
2025-01
0
64.36
2025-02
2
57.67
2025-03
6
83.62
2025-04
1
71.4
2025-05
0
81.16
2025-06
1
87.33
2025-07
0
119.88
2025-08
0
83.67
2025-09
0
81.89
2025-10
0
93.65
2025-11
0
83
2025-12
1
88.56
2026-01
0
74.52
2026-02
1
76.73
2026-03
0
87.13
2026-04
2
143.63
2026-05
0
327.5
2026-06
0
351.16
This device (reports/month)Average device in FRN, LGZ (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2025-01-02
Z-1099-2025
Class II
Open, Classified
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another setDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
1,029 cases (12,348 sets)
code info di
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-04-02
24765216
Malfunction
Available
model number
2026-02-20
1219702-2026-00008
Malfunction
Available
exact di
2025-12-22
1219702-2025-00069
Malfunction
Available
exact di
2025-06-18
1219702-2025-00032
Malfunction
Available
exact di
2025-04-24
1219702-2025-00026
Malfunction
Available
exact di
2025-03-27
1219702-2025-00021
Malfunction
Available
exact di
2025-03-27
21710380
Death
Available
model number
2025-03-14
21605244
Malfunction
Available
exact di
2025-03-06
1219702-2025-00017
Malfunction
Available
exact di
2025-03-06
1219702-2025-00018
Malfunction
Available
exact di
2025-02-12
1219702-2025-00011
Malfunction
Available
exact di
2025-02-12
1219702-2025-00010
Malfunction
Available
exact di
2024-10-18
1219702-2024-00051
Malfunction
Available
exact di
2024-10-17
1219702-2024-00048
Malfunction
Available
exact di
2024-10-10
1219702-2024-00047
Malfunction
Available
exact di
Showing the most recent 100 of 104 linked reports.
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.