Recall Z-2244-2023 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc.
Ventralight ST w EchoPS 4"x6" Ellipse- 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: 5955460G (EU Only)
| Date | Jul 27, 2023 (initiated Apr 25, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Product Recall letter on 4/25/23 via FedEx 2-day and email. Letter states reason for recall, health risk and action to take: 1. Please immediately discontinue use of the affected product. Check all inventory locations within your facility and destroy all affected product in accordance with your facility s process. 2. Share this notification with all users of the affected product within your facility network to ensure they are also aware of this product recall. 3. If you purchased the affected product from a distributor, contact your distributor directly for furt |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130968 | VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc., May 1, 2013 |