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 reportsMalfunction 2
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
4.33
2019-02
0
5.22
2019-03
0
5.13
2019-04
0
5.93
2019-05
0
5.62
2019-06
0
4.83
2019-07
0
5.82
2019-08
0
3.1
2019-09
0
3.7
2019-10
0
4.36
2019-11
0
3.78
2019-12
0
5.45
2020-01
0
4.56
2020-02
0
2.78
2020-03
0
4.5
2020-04
0
3.1
2020-05
0
2
2020-06
0
2.44
2020-07
0
3.77
2020-08
0
2.3
2020-09
0
4.22
2020-10
0
4.55
2020-11
0
4.6
2020-12
0
3.54
2021-01
0
3.67
2021-02
0
3.25
2021-03
0
4
2021-04
0
3.77
2021-05
0
2.92
2021-06
0
4.33
2021-07
0
2.92
2021-08
0
4.17
2021-09
0
3.43
2021-10
0
2.91
2021-11
0
3.36
2021-12
0
3.75
2022-01
0
4
2022-02
0
4.33
2022-03
0
3.4
2022-04
0
3.27
2022-05
0
6.4
2022-06
0
6.67
2022-07
0
5
2022-08
1
4.67
2022-09
1
2.93
2022-10
0
3.82
2022-11
0
3.18
2022-12
0
2.83
2023-01
0
3.67
2023-02
0
3.5
2023-03
0
3.69
2023-04
0
3.55
2023-05
0
3.39
2023-06
0
2.68
2023-07
0
3.75
2023-08
0
3.25
2023-09
0
3.07
2023-10
0
5.38
2023-11
0
3.22
2023-12
0
4.73
2024-01
0
4.55
2024-02
0
3.22
2024-03
0
2.73
2024-04
0
3.75
2024-05
0
2.14
2024-06
0
3.54
2024-07
0
2.58
2024-08
0
2.71
2024-09
0
3.21
2024-10
0
3.6
2024-11
0
3.43
2024-12
0
1.8
2025-01
0
5
2025-02
0
4.15
2025-03
0
4.33
2025-04
0
4.22
2025-05
0
4.45
2025-06
0
4.65
2025-07
0
5.56
2025-08
0
4.33
2025-09
0
2.5
2025-10
0
3.13
2025-11
0
4.64
2025-12
0
6.5
2026-01
0
4.29
2026-02
0
4.42
2026-03
0
5.57
2026-04
0
7.07
2026-05
0
11.14
2026-06
0
7.69
This device (reports/month)Average device in OCW (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2022-09-20
15454311
Malfunction
Available
catalog number
2022-08-30
15319484
Malfunction
Available
catalog number
Regulatory clearances
510(k)K172775Substantially equivalent (SESE) · 2018-02-12clearance family
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)