medical MODERATE Updated 2023-08-02

Davol, Inc. recalls Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number:

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Recalled Product

Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

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Hazard / Issue

Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Ventralight ST 4" x →
View official government recall