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ACCLARENT AERA

Model EU061655 · ACCLARENT, INC. · DI 10705031230880

PNZ — Eustachian Tube Balloon Dilation Device · Class II · 21 CFR 874.4180

UDILibrary device dossier · generated 2026-09-13 · 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 (14)

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.

Injury: 10 · Malfunction: 4

23562019-04: 2 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-05: 3 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 6/device2023-08: 2 reports for this device; peer average 2/device2024-01: 2 reports for this device; peer average 2/device2024-02: 2 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 2 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-06: 1 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device0409081003061012030506080102040708050612
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0422
2020-0901
2021-0803
2021-1003
2022-0306
2022-0603
2022-1001
2022-1201
2023-0301
2023-0533
2023-0606
2023-0822
2024-0122
2024-0222
2024-0402
2024-0701
2024-0822
2025-0501
2025-0611
2025-1201
This device (reports/month)Average device in PNZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ACCLARENT, INC.

  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations