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Adverse-event reports (MAUDE)

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.

14 linked reportsInjury 10Malfunction 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)
Failure-mode summaryAI-generated

14 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-06-303003418325-2025-00030InjuryAvailableexact di
2024-08-053005172759-2024-00084InjuryAvailablecatalog number
2024-02-083005172759-2024-00007InjuryAvailablecatalog number
2024-01-093005172759-2024-00004MalfunctionAvailablecatalog number
2023-08-243005172759-2023-00042MalfunctionAvailablecatalog number
2023-05-043005172759-2023-00028InjuryAvailablecatalog number
2019-04-153005172759-2019-00120InjuryAvailablecatalog number

Showing the most recent 7 of 14 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2020-09-25NAINo action indicatedAcclarent, Inc.0
2020-09-25NAINo action indicatedAcclarent, Inc.0
2013-12-09VAIVoluntary action indicatedAcclarent, Inc.0
2013-12-09VAIVoluntary action indicatedAcclarent, Inc.0
2013-03-20WLWarning LetterAcclarent, Inc.—
2013-03-20WLWarning LetterAcclarent, Inc.—
2013-02-22OAIOfficial action indicatedAcclarent, Inc.2
2013-02-22OAIOfficial action indicatedAcclarent, Inc.2
2012-06-14WLWarning LetterAcclarent, Inc.—
2012-06-14WLWarning LetterAcclarent, Inc.—
2012-02-24OAIOfficial action indicatedAcclarent, Inc.3
2012-02-24OAIOfficial action indicatedAcclarent, Inc.3
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