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 reportMalfunction 1
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
3.49
2019-02
0
3.51
2019-03
0
2.8
2019-04
0
3.52
2019-05
0
3.68
2019-06
0
3.14
2019-07
0
3.77
2019-08
0
3.83
2019-09
0
3.28
2019-10
0
4.5
2019-11
0
3.51
2019-12
0
3.51
2020-01
0
4.57
2020-02
0
3.84
2020-03
0
3.56
2020-04
0
3.89
2020-05
0
4.29
2020-06
0
4.44
2020-07
0
5.25
2020-08
0
4.21
2020-09
0
3.98
2020-10
0
2.69
2020-11
0
2.28
2020-12
0
2.04
2021-01
0
2.4
2021-02
0
2.41
2021-03
0
2.88
2021-04
0
2.61
2021-05
0
2.26
2021-06
0
2.3
2021-07
0
2.76
2021-08
0
2.69
2021-09
0
3.36
2021-10
0
3.12
2021-11
0
4.02
2021-12
0
3.19
2022-01
0
2.36
2022-02
0
3.05
2022-03
0
3.41
2022-04
0
3.03
2022-05
0
2.75
2022-06
0
3
2022-07
0
4.86
2022-08
0
2.91
2022-09
0
3.08
2022-10
0
1.97
2022-11
0
2.77
2022-12
0
2.6
2023-01
0
3.35
2023-02
0
2.59
2023-03
0
2.22
2023-04
0
2.41
2023-05
0
2.87
2023-06
0
2.46
2023-07
0
2.95
2023-08
0
2.82
2023-09
0
2.85
2023-10
0
2.53
2023-11
0
2.11
2023-12
0
2.37
2024-01
0
2.63
2024-02
0
2.52
2024-03
0
2.32
2024-04
0
2.75
2024-05
0
2.68
2024-06
1
2.95
2024-07
0
2.41
2024-08
0
2.49
2024-09
0
2
2024-10
0
2.46
2024-11
0
2.71
2024-12
0
2.1
2025-01
0
2.58
2025-02
0
2.14
2025-03
0
2.41
2025-04
0
1.73
2025-05
0
2.26
2025-06
0
2.08
2025-07
0
2.89
2025-08
0
2.48
2025-09
0
2.69
2025-10
0
2.46
2025-11
0
2.68
2025-12
0
2.61
2026-01
0
2.82
2026-02
0
2.75
2026-03
0
2.19
2026-04
0
2.99
2026-05
0
2.46
2026-06
0
2.96
This device (reports/month)Average device in LJS (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
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.
Manufacturer compliance record
Date
Type
Outcome
Facility
Citations
2026-01-15
NAI
No action indicated
Teleflex Medical OEM LLC
0
2024-03-18
NAI
No action indicated
Teleflex LLC (NADC)
0
2024-03-18
NAI
No action indicated
Teleflex LLC (NADC)
0
2024-01-26
NAI
No action indicated
Teleflex Medical OEM LLC
0
2022-12-09
NAI
No action indicated
Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company)