Gelseal™ 435028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881100128), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Perforation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K162803, P890045); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 17, 2018Material Perforation; Material Perforation

  EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: DURING PROCEDURE IT WAS FOUND THAT PROSTHESIS WAS PERFORATED ALONG ENTIRE LENGTH. DUE TO THE PATIENTS CONDITION THE BLEEDING SITE WAS STITCHED. NO PATIENT DEATH OR SERIOUS HARM REPORTED.

  Patient problems: No Information

  MAUDE report 7521273 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162803, P890045. One submission often covers many models, so check the product and lot details in each record.

• Z-1913-2015 · May 15, 2015 · Terminated
  Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, exclud
• Z-1912-2015 · May 15, 2015 · Terminated
  Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, exclud