Device product
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Z-2241-2023
Product summary
- Firm
- Davol, Inc.
- Event
- Event 92213
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1188 units US; 5 units OUS
- Official record key
device-enforcement:Z-2241-2023
Official wording
Reason: 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
Code information: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989
Distribution pattern: 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.
Derived failure modes
-
Unknown
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