Davol recalls Ventralight ST w Echo PS 4.5" Circle mesh for laparoscopic hernia repair due to potential balloon inflation failure, risking procedure delays or complications.
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
Davol is recalling Ventralight ST w Echo PS 4.5" Circle mesh for laparoscopic hernia repairs because the balloon might not inflate properly. This could cause surgery delays, improper mesh placement, or infections. Patients should contact their surgeon for guidance.
The mesh's balloon may not inflate as intended during surgery. If it doesn't inflate, the procedure might be delayed or prolonged, leading to improper mesh placement, erosion, migration, pain, or infection.
Patients who received this mesh during laparoscopic ventral hernia repair surgery are affected. Those with the mesh in place are at risk of complications if the balloon fails to inflate.
Check for the product name 'Ventralight ST w Echo PS 4.5" Circle' on the mesh. The catalog number is 5955450G (EU only) and lot number HUGT1609.
Patients should contact their surgeon to discuss whether the mesh is part of the recall and next steps.
The recall states the balloon may not inflate as intended, which could lead to complications. Patients should not use it without consulting their surgeon.
Contact your surgeon to determine if the mesh is part of the recall and what actions to take.
The recall does not mention a fix; patients must contact their surgeon for guidance.
We’ve drafted a message you can send Davol to request your refund or repair — edit it as you like.
Subject: Recall Z-2243-2023 — Davol Davol Hello, I own a Davol that is covered by recall Z-2243-2023 from Davol. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
