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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
2025-04-11Z-1717-2025Class IOpen, ClassifiedInadequate weld that can potentially cause the product to disassemble.Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.1,840 unitsclearance family
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
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