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.
87 linked reportsInjury 79Malfunction 8
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
1.9
2019-02
2
1.67
2019-03
0
1.12
2019-04
2
1.52
2019-05
0
1.23
2019-06
0
1.89
2019-07
4
2.52
2019-08
4
2
2019-09
2
2.33
2019-10
0
1.37
2019-11
2
1.77
2019-12
0
2.13
2020-01
2
1.5
2020-02
0
1.5
2020-03
0
1.82
2020-04
2
1.73
2020-05
0
1.67
2020-06
0
1.82
2020-07
2
2.14
2020-08
2
1.55
2020-09
0
1.93
2020-10
0
1.78
2020-11
1
1.3
2020-12
0
2.29
2021-01
0
2
2021-02
1
1.25
2021-03
0
1.38
2021-04
0
1.55
2021-05
0
2.31
2021-06
2
1.85
2021-07
0
2.29
2021-08
2
1.8
2021-09
0
1.84
2021-10
4
1.9
2021-11
1
2.11
2021-12
0
1.63
2022-01
0
2.29
2022-02
0
2.27
2022-03
0
1.6
2022-04
0
1.85
2022-05
0
2
2022-06
0
2.53
2022-07
4
2.23
2022-08
0
2.1
2022-09
2
2.2
2022-10
2
2.29
2022-11
2
2
2022-12
0
2
2023-01
0
2.36
2023-02
2
2.78
2023-03
1
1.92
2023-04
6
3.92
2023-05
0
3
2023-06
0
2.23
2023-07
3
2.19
2023-08
2
2.5
2023-09
0
2.17
2023-10
0
2.1
2023-11
0
2.67
2023-12
0
2.63
2024-01
0
1.71
2024-02
0
1.19
2024-03
0
2.22
2024-04
6
2.33
2024-05
1
1.92
2024-06
4
2.75
2024-07
2
2.33
2024-08
2
2.08
2024-09
0
2
2024-10
3
1.78
2024-11
0
2.44
2024-12
3
1.8
2025-01
0
2.2
2025-02
3
2.25
2025-03
0
1.89
2025-04
0
1.38
2025-05
0
1.56
2025-06
0
1.83
2025-07
0
2.08
2025-08
1
1.67
2025-09
0
1.4
2025-10
0
2.2
2025-11
0
2
2025-12
2
2.9
2026-01
0
2.38
2026-02
0
2.71
2026-03
0
2
2026-04
0
3.36
2026-05
0
1.67
2026-06
0
1.83
This device (reports/month)Average device in NRA (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
2020-04-17
Z-2148-2020
Class II
Terminated
Potential presence of elevated endotoxin levels that exceed the specification limitDistribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.