Device product

Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)

Z-2243-2023

April 25, 2023

Class II

Product summary

Firm: Davol, Inc.
Event: Event 92213
Status: Ongoing
Classification: Class II
Quantity: 169 units
Official record key: device-enforcement:Z-2243-2023

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)00801741201950(17)240528(10) Lot Number HUGT1609

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
reason.no_named_rule · v1.0.0

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