The Recall Desk
HighFDA (Devices)·Z-2243-2023·Announced 2023-08-02

Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

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 an FDA Class II medical device recall for a potential failure mode that could result in inadequate surgical repair, mesh migration, erosion, and infection. While no illnesses or injuries are reported in the source text, the hazard presents significant risk of patient harm during and after surgery.

Plain-English summary

Davol, Inc. is recalling the Ventralight ST w Echo PS 4.5" Circle surgical mesh, a bioresorbable implant designed for laparoscopic ventral hernia repair. The device includes a pre-attached removable positioning system and is distributed worldwide, including throughout the United States and Europe.

The balloon component of the device may not inflate as intended during surgery. If inflation fails, the procedure may be delayed or prolonged, and the mesh may not be placed adequately. This can lead to erosion or migration of the mesh, patient pain, and mesh infection.

The recall affects 169 units identified by Lot Number HUGT1609. The device was distributed worldwide to the United States and to Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, India, Hong Kong, Greece, Chile, and Colombia.

Healthcare facilities and surgeons who have received this device should contact Davol, Inc. for instructions on returns or replacements. Patients who have received this implant should consult their healthcare provider if they experience pain, fever, or other signs of infection.

The recalled product

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 on
Manufacturer
Davol, Inc.
Category
Medical Device — Surgical Implant / Hernia Repair
Hazard
  • device-malfunction
  • inadequate-mesh-placement
  • infection-risk
  • erosion-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)00801741201950(17)240528(10) Lot Number HUGT1609

Distribution

Distributed nationwide across the United States.

Related recalls

Same category