The Recall Desk
HighFDA (Devices)·Z-2241-2023·Announced 2023-08-02

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.

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 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.
Category
Medical Device — Surgical Implant / Hernia Repair
Hazard
  • device-malfunction
  • mesh-migration
  • surgical-complication
  • infection-risk

Distribution

Distributed nationwide across the United States.

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