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Davol, Inc. recalls Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Recalled August 2, 2023 · FDA recall Z-2241-2023 · Davol
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 · FDA Class II
Units
1188 units US; 5 units OUS
Sold at
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.
Description
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
Product
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Manufacturer(s)
Davol, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →