Recall Z-0445-2011 ยท OGX
Volcano Corporation
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.
| Date | Nov 23, 2010 (initiated Nov 3, 2010) |
| Status | Terminated |
| Reason | Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury. |
| Root cause | Device Design |
| Action | Firm initiated recall on 11/03/2010, and sent notifications to its consignees via letter. The firm has requested that consignees provide the notification to all personnel within the organization and letters will be sent directly to known customers on 11/04/2010 by Volcano. Customers have been instructed to cease use and contact customer service to arrange returns, and credit will be issued. |
| Quantity | 4724 units |
| Distribution | Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071529 | XTRACT CATHETER SYSTEM Lumen Biomedical, Inc., Aug 10, 2007 |