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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
2021-08-31Z-0158-2022Class IIOpen, ClassifiedThere was an increase in complaints related to tip breaks and wobble/vibration.Distribution: Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.274,991 total devicescode info di
Regulatory clearances

    Predicate lineage

    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
    2024-06-17VAIVoluntary action indicatedMedtronic Xomed, Inc.1
    2021-10-29VAIVoluntary action indicatedMedtronic Xomed, Inc.5
    2015-09-21VAIVoluntary action indicatedMedtronic Xomed, Inc.1
    2012-07-03VAIVoluntary action indicatedMedtronic Xomed, Inc.8
    2012-06-06NAINo action indicatedMedtronic Xomed, Inc.0
    2010-08-05VAIVoluntary action indicatedMedtronic Xomed, Inc.4
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