Hernia repair implant balloon may not inflate as intended
Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 without any reported injuries or illnesses. While the device failure could result in serious surgical complications, the hazard remains theoretical. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
Davol, Inc. is recalling the Ventralight ST 4" x 6" Ellipse with Echo PS (Catalog Number 5955460), a balloon implant used in laparoscopic ventral hernia repair procedures. The device balloon may not inflate as intended.
If the balloon fails to inflate during surgery, the procedure may be delayed or prolonged. This could result in inadequate mesh placement, erosion or migration of the implant, pain, and mesh infection.
The recall affects 1,188 units distributed in the United States and 5 units distributed outside the US in Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, India, Hong Kong, Greece, Chile, and Colombia. The affected lot numbers are HUGS0481, HUGS0549, HUGS1019, HUGS2031, HUGS2079, HUGT1627, HUGS2025, and HUGT1989.
The recalled product
- Product
- Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
- Manufacturer
- Davol, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Davol, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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