medical MODERATE Updated 2023-08-02

Davol, Inc. recalls Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, biores

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Recalled Product

Ventralight ST w EchoPS 4"x6" Ellipse- 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: 5955460G (EU Only)

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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)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988

✅ 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.

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If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

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