Device Recall Lumen Biomedical Xtract Aspiration Catheter system

Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.

Cardiovascular Devices

Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria

Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.