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.
3 linked reportsMalfunction 3
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
1.33
2019-04
0
1.33
2019-05
0
2
2019-07
0
1.5
2019-10
0
1
2019-11
0
4
2020-01
0
2
2020-02
0
4
2020-03
0
1
2020-04
0
1.5
2020-06
0
1
2020-07
0
1
2020-10
0
1
2020-11
0
6
2021-01
0
1.33
2021-04
0
1
2021-06
0
1
2021-07
0
1.5
2021-09
0
1
2021-10
0
1
2021-11
0
2.67
2021-12
0
1
2022-01
0
1
2022-03
0
2.67
2022-04
0
1.17
2022-06
0
2.5
2022-07
0
1.33
2022-08
0
1
2022-09
0
1.25
2022-10
0
1.33
2022-12
0
2.17
2023-01
0
1.09
2023-02
0
1
2023-03
0
8.29
2023-04
0
3.33
2023-05
0
1.25
2023-06
0
4.88
2023-07
0
2
2023-08
2
1.5
2023-09
0
1.33
2023-10
0
1.67
2023-11
0
1
2023-12
0
1.67
2024-01
0
1.67
2024-02
0
1
2024-03
0
1
2024-04
0
1.5
2024-05
0
2
2024-06
0
1
2024-07
0
1.75
2024-08
0
1
2024-09
0
1.5
2024-10
0
1.8
2024-11
0
1.33
2024-12
0
3.4
2025-01
0
1.67
2025-02
0
5
2025-03
0
3.4
2025-04
0
1.2
2025-05
0
1.5
2025-06
0
2.5
2025-07
1
2
2025-08
0
2.25
2025-09
0
1
2025-10
0
1.5
2025-11
0
1
2026-01
0
1
2026-03
0
1
2026-04
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in KCY (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2026-06-09
Z-2674-2026
Class II
Open, Classified
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.Distribution: Worldwide distribution - US Nationwide and the countries of Canada and EMEA.