Recall Z-2012-2024— Atrium Medical Corporation

Name: FDA recall Z-2012-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-03

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2024-05-03. It names 2 FDA 510(k) clearances: K071923, K060124. Product: FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft. Reason: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-05-03
Firm location: Merrimack, NH, United States

510(k) clearances named in this recall

2 on FDA's record

K071923 — PTFE FLIXENE GRADUATED WALL GRAFTAtrium Medical Corp.·cleared 2007-08-14
K060124 — ATRIUM FLIXENE GRAFTAtrium Medical Corp.·cleared 2006-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Reason for recall

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Data sourced from openFDA. This site is unofficial and independent of the FDA.