Skip to content
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.

1 linked reportMalfunction 1
61117222019-01: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 22/device2021-04: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-09: 1 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device011004070903090712020205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-10022
2021-0402
2021-0701
2021-0911
2022-0301
2022-0901
2023-0701
2023-1205
2024-0202
2025-0201
2025-0502
This device (reports/month)Average device in HBO (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
DateReport #TypeNarrativeLink basis
2021-09-223014334038-2021-00196MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-05-02NAINo action indicatedCerenovus0
2016-09-30VAIVoluntary action indicatedCerenovus Inc1
2016-09-21VAIVoluntary action indicatedCerenovus, Inc.1
2016-09-21VAIVoluntary action indicatedCerenovus, Inc.1
2015-10-22NAINo action indicatedCerenovus Inc0
2015-10-22NAINo action indicatedCerenovus Inc0
2014-03-14VAIVoluntary action indicatedCerenovus Inc4
2013-11-05VAIVoluntary action indicatedCerenovus, Inc.6
2013-11-05VAIVoluntary action indicatedCerenovus, Inc.6
2011-09-27NAINo action indicatedCerenovus, Inc.0
2011-09-27NAINo action indicatedCerenovus, Inc.0
2011-03-04VAIVoluntary action indicatedCerenovus, Inc.1
2011-03-04VAIVoluntary action indicatedCerenovus, Inc.1
2010-12-30VAIVoluntary action indicatedCerenovus Inc7
2010-06-17NAINo action indicatedCerenovus, Inc.0
2010-06-17NAINo action indicatedCerenovus, Inc.0
Similar devices
Select up to two to place side-by-side with this device.