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TubaVent® balloon dilatation system
Model 2080-3045-US · Spiggle & Theis Medizintechnik GmbH · DI 04250676745088
PNZ — Eustachian Tube Balloon Dilation Device · Class II · 21 CFR 874.4180
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-04
0
2
2020-09
0
1
2021-08
0
3
2021-10
0
3
2022-03
0
6
2022-06
0
3
2022-10
0
1
2022-12
0
1
2023-03
0
1
2023-05
0
3
2023-06
0
6
2023-08
0
2
2024-01
0
2
2024-02
0
2
2024-04
0
2
2024-07
0
1
2024-08
0
2
2025-05
0
1
2025-06
0
1
2025-12
0
1
This device (reports/month)Average device in PNZ (reports/device/month)