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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.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2019-09-19Z-0149-2020Class IITerminatedThe sterile barrier of some devices may have been affectedDistribution: Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico464,040 eachesclearance family
2019-09-19Z-0150-2020Class IITerminatedThe sterile barrier of some devices may have been affectedDistribution: Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico460,000 eachesclearance family
2019-09-19Z-0151-2020Class IITerminatedThe sterile barrier of some devices may have been affectedDistribution: Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico255,000 eachcode info di
Regulatory clearances

    Predicate lineage

    K053433

    Cited as predicate by: K151222, K182080

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    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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