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.
2 linked reportsInjury 1Malfunction 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
2.43
2019-02
0
5.57
2019-03
0
3.31
2019-04
0
3.13
2019-05
0
3.18
2019-06
0
4.4
2019-07
0
4.12
2019-08
0
4.31
2019-09
0
3
2019-10
0
3.18
2019-11
0
2.79
2019-12
0
2.76
2020-01
0
3
2020-02
0
2
2020-03
0
1.95
2020-04
0
1.58
2020-05
0
1.59
2020-06
0
1.36
2020-07
0
1.66
2020-08
0
1.63
2020-09
0
1.27
2020-10
0
3.21
2020-11
0
2
2020-12
0
1.94
2021-01
0
2.15
2021-02
0
2.29
2021-03
0
3
2021-04
0
2.25
2021-05
0
1.92
2021-06
0
2.94
2021-07
0
2.11
2021-08
0
1.67
2021-09
0
2.53
2021-10
0
1.78
2021-11
0
2.21
2021-12
0
2.07
2022-01
0
3.18
2022-02
0
1.95
2022-03
0
1.72
2022-04
0
2.18
2022-05
0
2
2022-06
0
1.88
2022-07
0
1.91
2022-08
0
2.24
2022-09
0
2.29
2022-10
0
2.63
2022-11
0
2.55
2022-12
0
3.08
2023-01
0
2
2023-02
0
2.33
2023-03
0
3.53
2023-04
0
2.35
2023-05
0
3.06
2023-06
0
3
2023-07
0
2.07
2023-08
2
1.73
2023-09
0
2.68
2023-10
0
2.07
2023-11
0
2.35
2023-12
0
2.42
2024-01
0
1.31
2024-02
0
1.65
2024-03
0
1.7
2024-04
0
2.05
2024-05
0
3.3
2024-06
0
2
2024-07
0
2.6
2024-08
0
4.13
2024-09
0
1.93
2024-10
0
2.2
2024-11
0
2.35
2024-12
0
2.87
2025-01
0
6.57
2025-02
0
3.35
2025-03
0
2.83
2025-04
0
4.22
2025-05
0
2.25
2025-06
0
5.19
2025-07
0
2.14
2025-08
0
3.48
2025-09
0
3.79
2025-10
0
4.05
2025-11
0
3.4
2025-12
0
3.96
2026-01
0
2.65
2026-02
0
8.61
2026-03
0
3.77
2026-04
0
3.62
2026-05
0
5.05
2026-06
0
2.46
This device (reports/month)Average device in FCG (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives 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)