VENTRALIGHT 5990020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741131035), received between May 19, 2022 and May 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2020 - SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED FIRST TIME RECURRENT RIGHT INCISIONAL HERNIA (10X8CM) REPAIR USING A BARD/DAVOL VENTRALIGHT ST MESH W/ECHO 2 PS. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. (B)(6) 2020 - CT SCAN REVEALED NORMAL POST-OP CHANGES WITH A SEROMA WHICH WAS NOT UNEXPECTED AND NO SURGICAL PROCEDURE WAS PERFORMED FOR THE SEROMA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14438324 ↗