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.
2 linked reportsMalfunction 2
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
5.73
2019-02
0
4.31
2019-03
0
6.81
2019-04
0
11.45
2019-05
0
4.9
2019-06
0
3.38
2019-07
0
8.59
2019-08
0
3.2
2019-09
0
2.71
2019-10
0
3.25
2019-11
0
5.37
2019-12
0
4.08
2020-01
0
3.67
2020-02
0
5.73
2020-03
0
3.86
2020-04
0
3.87
2020-05
0
5.48
2020-06
0
4.85
2020-07
0
11.05
2020-08
0
7.33
2020-09
0
7.69
2020-10
0
8.46
2020-11
0
9.01
2020-12
0
10.62
2021-01
0
10.26
2021-02
0
10
2021-03
0
16.23
2021-04
0
13.02
2021-05
0
11.44
2021-06
0
9.92
2021-07
0
10.83
2021-08
0
11.07
2021-09
0
14.15
2021-10
0
9.93
2021-11
0
11.77
2021-12
0
14.3
2022-01
0
11.09
2022-02
0
13.57
2022-03
0
15.01
2022-04
0
15.04
2022-05
0
15.31
2022-06
0
15.53
2022-07
0
11.22
2022-08
0
10.97
2022-09
0
10.43
2022-10
0
11.34
2022-11
0
9.56
2022-12
0
10.7
2023-01
0
10.38
2023-02
0
11.31
2023-03
0
12.74
2023-04
0
10.68
2023-05
0
11.4
2023-06
0
9.56
2023-07
0
10.37
2023-08
0
11.96
2023-09
1
11.55
2023-10
0
12.63
2023-11
0
12.78
2023-12
0
11.92
2024-01
0
14.58
2024-02
0
13.59
2024-03
0
14.75
2024-04
0
12.71
2024-05
0
11.49
2024-06
0
13.74
2024-07
0
12.77
2024-08
0
12.26
2024-09
0
12.54
2024-10
0
16.46
2024-11
0
10.02
2024-12
0
6.66
2025-01
0
7.81
2025-02
0
6.46
2025-03
0
8.1
2025-04
0
8.27
2025-05
0
8.34
2025-06
0
8.83
2025-07
0
8.9
2025-08
0
10.07
2025-09
1
7.78
2025-10
0
13.1
2025-11
0
19.31
2025-12
0
34.71
2026-01
0
30.03
2026-02
0
17.76
2026-03
0
16.59
2026-04
0
26.61
2026-05
0
31.08
2026-06
0
27.76
This device (reports/month)Average device in FDT, FEB, NWB (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2023-07-27
Z-2467-2023
Class II
Open, Classified
Recent reports of patient infection.Distribution: US Nationwide distribution.
6,426 units
clearance family
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-09-12
9610595-2025-20788
Malfunction
Available
exact di
2023-09-12
9610595-2023-13228
Malfunction
Available
exact di
Regulatory clearances
510(k)K202661Substantially equivalent (SESE) · 2020-12-08clearance family
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.