The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
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
1.78
2019-02
0
2
2019-03
0
2.22
2019-04
0
1.9
2019-05
0
1.57
2019-06
0
1.77
2019-07
0
1.96
2019-08
0
3.12
2019-09
0
1.89
2019-10
0
2.26
2019-11
0
1.97
2019-12
0
2.03
2020-01
0
2.74
2020-02
0
1.77
2020-03
0
2.33
2020-04
0
1.96
2020-05
0
2
2020-06
0
2.4
2020-07
0
2.12
2020-08
0
2.1
2020-09
0
1.25
2020-10
0
1.8
2020-11
0
1.41
2020-12
0
2.05
2021-01
0
1.39
2021-02
0
1.36
2021-03
0
1.48
2021-04
0
1.57
2021-05
0
1.27
2021-06
0
1.41
2021-07
0
2.24
2021-08
0
2.95
2021-09
0
1.71
2021-10
0
2.35
2021-11
0
2.1
2021-12
0
1.8
2022-01
0
1.92
2022-02
0
2.17
2022-03
0
2.54
2022-04
0
2.79
2022-05
0
1.96
2022-06
0
2.89
2022-07
0
1.78
2022-08
0
2.06
2022-09
0
1.67
2022-10
0
2.14
2022-11
0
2.57
2022-12
0
2.58
2023-01
0
2.7
2023-02
0
1.88
2023-03
0
3.08
2023-04
0
2
2023-05
0
2.33
2023-06
0
2.07
2023-07
0
2.5
2023-08
0
2.05
2023-09
0
1.7
2023-10
1
1.58
2023-11
0
2.23
2023-12
0
2.3
2024-01
0
2
2024-02
0
2.26
2024-03
0
1.64
2024-04
0
1.81
2024-05
0
2.43
2024-06
0
2.12
2024-07
0
2.03
2024-08
0
2.15
2024-09
0
2.21
2024-10
0
2.22
2024-11
0
2
2024-12
0
2.85
2025-01
0
2.64
2025-02
0
2.5
2025-03
0
2.25
2025-04
0
2.05
2025-05
0
2.76
2025-06
0
2.68
2025-07
0
3.09
2025-08
0
2.34
2025-09
0
4.45
2025-10
0
2.75
2025-11
0
4.15
2025-12
0
2.97
2026-01
0
6.72
2026-02
0
3.26
2026-03
0
3.38
2026-04
0
2.97
2026-05
0
3.93
2026-06
0
3.45
This device (reports/month)Average device in DQO (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2023-10-12
17919448
Malfunction
Available
catalog number
Regulatory clearances
None linked.
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)