Gelsoft™ Cardiovascular Patch 960501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881010625), received between Feb 9, 2017 and Feb 9, 2017 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K200955, K963611); 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 9, 2017Hole In Material; Hole In Material

  THE EVENT WAS DESCRIBED TO VASCUTEK AS; A CAROTID TEA HAS BEEN PERFORMED. AFTER IMPLANT AND RELEASE OF THE BLOOD FLOW HOLES IN THE MIDDLE OF THE PATCH WERE OBSERVED. BLOOD WAS LEAKING THROUGH THE HOLES. ADDITIONAL SUTURES WERE REQUIRED TO CLOSE THE HOLES.

  Patient problems: No Information

  MAUDE report 6313686 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200955, K963611. One submission often covers many models, so check the product and lot details in each record.

• Z-2543-2021 · Jul 8, 2021 · Terminated
  The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t