Hernia repair mesh balloon may not inflate during surgery
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
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 recall involving a surgical mesh with a potential equipment malfunction (balloon inflation failure) that could result in serious complications including mesh migration and infection. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported, placing it at severity level 3.
Plain-English summary
Davol, Inc. is recalling 1,599 units of the Ventralight ST 4.5" Circle with Echo PS surgical mesh worldwide. The mesh is designed to reconstruct soft tissue defects during laparoscopic ventral hernia repair surgery. Affected units are identified by lot numbers HUGS0922, HUGS2026, HUGS2061, HUGS2020, HUGS2044, HUGS2015, HUGS2076, HUGT1582, HUGU0750, and HUGU0748.
The product includes a balloon-based positioning system that may fail to inflate properly during surgery. If the balloon does not inflate as intended, the surgeon may be unable to position the mesh correctly, which can result in inadequate mesh placement.
Potential consequences of balloon inflation failure include delayed or prolonged surgery, mesh erosion or migration, post-operative pain, and mesh infection. No illnesses or adverse events have been reported to date.
Patients or healthcare providers with questions about affected units should contact Davol, Inc. or consult their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Davol, Inc.
- Hazard
- equipment-malfunction
- mesh-migration
- infection-risk
Distribution
Distributed nationwide across the United States.
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