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U.S. Department of Health and Human Services

Class 2 Device Recall Ventralight" ST Mesh with Echo PS" Positioning System

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  Class 2 Device Recall Ventralight" ST Mesh with Echo PS" Positioning System see related information
Date Initiated by Firm April 25, 2023
Date Posted July 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-2243-2023
Recall Event ID 92213
510(K)Number K130968  
Product Classification Mesh, surgical, polymeric - Product Code FTL
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
Catalog Number: 5955450G (EU only)

Code Information UDI-DI: (01)00801741201950(17)240528(10) Lot Number HUGT1609
Recalling Firm/
Davol, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact SAME
Manufacturer Reason
for Recall
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 Determined
Cause 2
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 further instructions and credit resolution. 4. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the affected product so that BD may acknowledge your receipt of this notification per FDA requirements. 5. Indicate on the response form the quantity of affected product identified at your facility and confirm that this product inventory was destroyed. 6. Please contact your BD representative if you require assistance with this process, or you may also contact BD. 1. BD will issue replacements for destroyed product to customers that purchased product directly from BD following receipt of the completed Customer Response Form. 2. BD is implementing actions to prevent recurrence of this product issue. Contact Information: If you require further assistance please contact: BD Contact Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com Recall questions, Product Complaints, Technical Questions
Quantity in Commerce 169 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = C.R. BARD, INC.