Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syring
FDA device recall Z-0445-2011 · posted 2010-11-23 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OGX
- Quantity affected
- 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
- Date initiated
- 2010-11-03
- Date posted
- 2010-11-23
- Date terminated
- 2011-12-07
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XTRACT CATHETER SYSTEM (K071529) | Lumen Biomedical, Inc. | 2007-08-10 |