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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.

2 linked reportsMalfunction 2
11222020-06: 2 reports for this device; peer average 2/device06
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0622
This device (reports/month)Average device in LYV (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2020-06-193014527682-2020-00006MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-06NAINo action indicatedXodus Medical Inc0
2026-02-06NAINo action indicatedXodus Medical Inc0
2019-08-14VAIVoluntary action indicatedXodus Medical Inc7
2019-08-14VAIVoluntary action indicatedXodus Medical Inc7
2017-10-10NAINo action indicatedXodus Medical Inc0
2017-10-10NAINo action indicatedXodus Medical Inc0
2015-07-10NAINo action indicatedXodus Medical Inc0
2015-07-10NAINo action indicatedXodus Medical Inc0
2013-02-19VAIVoluntary action indicatedXodus Medical Inc2
2013-02-19VAIVoluntary action indicatedXodus Medical Inc2
2012-09-21NAINo action indicatedXodus Medical Inc0
2012-09-21NAINo action indicatedXodus Medical Inc0
2010-09-13NAINo action indicatedXodus Medical Inc0
2010-09-13NAINo action indicatedXodus Medical Inc0
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