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.
1 linked reportInjury 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
4.33
2019-03
0
2
2019-04
0
1.5
2019-05
0
2
2019-06
0
3.5
2019-07
0
3.33
2019-08
0
4
2019-09
0
1.5
2019-10
0
3
2019-11
0
13
2019-12
0
1
2020-01
0
3.6
2020-02
0
1
2020-03
0
1.5
2020-04
0
2.33
2020-05
0
1.5
2020-07
0
2
2020-08
0
3
2020-09
0
1
2020-10
0
4
2020-11
0
3
2020-12
0
4
2021-01
1
1
2021-03
0
4
2021-04
0
5
2021-05
0
3
2021-06
0
4
2021-07
0
3
2021-08
0
13
2021-09
0
25.5
2021-10
0
19.5
2021-11
0
12.5
2021-12
0
13.5
2022-01
0
6.25
2022-02
0
6.5
2022-03
0
17.5
2022-04
0
23
2022-05
0
6.5
2022-06
0
5
2022-07
0
3.67
2022-08
0
8.33
2022-09
0
14.5
2022-10
0
5.25
2022-11
0
21
2022-12
0
6.33
2023-01
0
11
2023-02
0
20
2023-03
0
20.57
2023-04
0
15.57
2023-05
0
14.2
2023-06
0
10.29
2023-07
0
7
2023-08
0
13.33
2023-09
0
7
2023-10
0
9.75
2023-11
0
12.71
2023-12
0
5.57
2024-01
0
8.8
2024-02
0
16.14
2024-03
0
9.71
2024-04
0
11.67
2024-05
0
13.25
2024-06
0
9.83
2024-07
0
11.29
2024-08
0
8
2024-09
0
15.25
2024-10
0
21.25
2024-11
0
16
2024-12
0
7
2025-01
0
10.2
2025-02
0
3.25
2025-03
0
7.63
2025-04
0
7.25
2025-05
0
6.89
2025-06
0
11.75
2025-07
0
12
2025-08
0
6.13
2025-09
0
3.57
2025-10
0
6.4
2025-11
0
7.33
2025-12
0
7.6
2026-01
0
5.33
2026-02
0
4.67
2026-03
0
10.6
2026-04
0
9.57
2026-05
0
6.5
2026-06
0
6.38
This device (reports/month)Average device in BTA (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2020-12-02
Z-1502-2021
Class II
Terminated
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA,FL,GA, IL, MA, MI, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WV. The country of Netherlands.