The Recall Desk
HighFDA (Devices)·Z-2244-2023·Announced 2023-08-02

Surgical mesh inflation malfunction in Ventralight ST hernia repair device

Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall where the positioning balloon may fail to inflate, potentially compromising surgical mesh placement. No deaths, hospitalizations, or confirmed injuries have been reported. The device creates theoretical risk of serious surgical complications including inadequate placement, mesh erosion, migration, and infection, meeting the criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Davol, Inc. is recalling Ventralight ST w EchoPS 4"x6" Ellipse surgical mesh devices (Catalog Number 5955460G), used in laparoscopic ventral hernia repair procedures. The device is designed with a pre-attached removable positioning system that includes a balloon component.

The balloon may fail to inflate properly during the surgical procedure. If inflation does not occur as intended, the procedure may be delayed or prolonged, and the mesh may not be placed adequately within the surgical site.

Inadequate mesh placement could result in mesh erosion or migration, pain, and infection. The affected lots are HUGS2043 and HUGT1988, with worldwide distribution including the United States, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.

Patients and healthcare providers with questions about this device or recall should contact Davol, Inc. directly or refer to the FDA recall notice.

The recalled product

Product
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 On
Manufacturer
Davol, Inc.
Category
Medical Device — Surgical Mesh
Hazard
  • inflation-failure
  • inadequate-placement
  • mesh-erosion
  • mesh-migration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: (01)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988

Distribution

Distributed nationwide across the United States.

Related recalls

Same category