FDA-Device2023-08-02Class II
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Davol, Inc.
Hazard
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Affected count
1188 units US; 5 units OUS
Manufactured in
100 Crossings Blvd, N/A, Warwick, RI, United States
Products
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2241-2023Don't want to check this manually?
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