Every recall we track for Vascutek, Ltd. — 3 in all — plus the complaints and injury reports the public filed about them.
Vascutek recalls Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from gel impregnation (date of manufacture) but was incorrectly calculated from device packaging.
Vascutek recalls instructions for use for carotid and gelsoft vascular patches due to incorrect distribution to U.S. customers. No action needed as the issue is with shipping labels, not the product itself.
Vascutek recalls certain Gelsoft vascular grafts due to incorrect Instructions for Use distribution to international consignees instead of U.S. consignees. No action required for users.
