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.
69 linked reportsMalfunction 65Injury 4
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
3.25
2019-02
0
4
2019-03
0
1.5
2019-04
0
3
2019-05
0
2.4
2019-06
0
2
2019-07
0
3.33
2019-08
0
3.83
2019-09
0
2.5
2019-10
0
3.17
2019-11
0
3
2019-12
0
3.4
2020-01
0
2.78
2020-02
0
2.17
2020-03
0
3.67
2020-04
0
3.33
2020-05
0
3
2020-06
0
4.78
2020-07
0
35
2020-08
0
20
2020-09
0
21
2020-10
0
13.6
2020-11
0
47.5
2020-12
0
9.88
2021-01
0
9.14
2021-02
0
14.33
2021-03
0
14.25
2021-04
0
11.09
2021-05
0
12
2021-06
0
6
2021-07
0
1.63
2021-08
0
1
2021-09
0
1
2021-10
0
1.25
2021-11
0
1.64
2021-12
0
1.33
2022-01
0
1.6
2022-02
0
6.6
2022-03
0
1.86
2022-04
0
1.67
2022-05
0
1.4
2022-06
0
2.14
2022-07
0
1.29
2022-08
0
1.09
2022-09
0
2.17
2022-10
0
1.64
2022-11
0
1.5
2022-12
0
1.54
2023-01
0
2
2023-02
0
2
2023-03
1
2
2023-04
1
1.26
2023-05
3
2.14
2023-06
2
2.75
2023-07
0
1.5
2023-08
1
1.57
2023-09
0
1.36
2023-10
0
1.83
2023-11
1
1.44
2023-12
1
1.7
2024-01
1
1.92
2024-02
2
2.89
2024-03
0
1.73
2024-04
0
2.33
2024-05
3
2.22
2024-06
2
2.57
2024-07
1
2.31
2024-08
3
4.25
2024-09
3
2.13
2024-10
4
3.42
2024-11
6
3.71
2024-12
3
2.57
2025-01
4
2
2025-02
7
3.58
2025-03
7
5.86
2025-04
0
1.75
2025-05
0
1.8
2025-06
0
2.13
2025-07
2
1.61
2025-08
3
1.75
2025-09
0
1
2025-10
0
2
2025-11
1
2
2025-12
0
1.1
2026-01
0
2.2
2026-02
1
1.5
2026-03
4
2.43
2026-04
1
1.79
2026-05
1
2.17
2026-06
0
1.5
This device (reports/month)Average device in GDC, JEA, KXJ (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
2024-09-19
Z-0210-2025
Class II
Open, Classified
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.Distribution: Worldwide distribution.