Gelseal™ 431508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881100340), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionFeb 23, 2017Leak/Splash; Leak/Splash

  THIS RECORD IS A FOLLOW UP #1 REPORT REGARDING MFR#9612515-2017-00004 THAT WAS SUBMITTED TO THE FDA ON FEBRUARY 23RD 2017.

  Patient problems: No Information

  MAUDE report 6351998 ↗

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-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
• 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