Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, wi...

FDA Device Recall #Z-2242-2023 — Class II — April 25, 2023

Recall Summary

Recall Number Z-2242-2023
Classification Class II — Moderate risk
Date Initiated April 25, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Davol, Inc.
Location Warwick, RI
Product Type Devices
Quantity 1599 units

Product Description

Ventralight ST 4.5" Circle with Echo PS- 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: 5955450

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

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.

Lot / Code Information

UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: Lot Number HUGS0922 HUGS2026 HUGS2061 HUGS2020 HUGS2044 HUGS2015 HUGS2076 HUGT1582 HUGU0750 HUGU0748

Other Recalls from Davol, Inc.

Recall # Classification Product Date
Z-2243-2023 Class II Ventralight ST w Echo PS 4.5" Circle A low pr... Apr 25, 2023
Z-2244-2023 Class II Ventralight ST w EchoPS 4"x6" Ellipse- A low pr... Apr 25, 2023
Z-2241-2023 Class II Ventralight ST 4" x 6" Ellipse with Echo PS Ca... Apr 25, 2023
Z-1457-2022 Class II X-Stream Irrigation System (Catalog No. 5551000... Jun 27, 2022
Z-1305-2022 Class II HydroSurg Plus Laparoscopic Irrigator with Nezh... Jun 7, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.