Vascutek, Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2543-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Product Classification:

Class II

Date Initiated: July 8, 2021

Date Posted: October 6, 2021

Recall Number: Z-2543-2021

Event ID: 88278

Reason for Recall:

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Status: Terminated

Product Quantity: 159 total vascular grafts and patches

Code Information:

To be reported.

Distribution Pattern:

Distribution was made to PR and Guam.

Voluntary or Mandated:

Voluntary: Firm initiated