Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston S
FDA device recall Z-0107-2010 · posted 2009-11-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
- Action taken
- The firm initiated its 'Safety Alert' on October 6, 2009. A notification letter was sent to each customer reminding them to follow storage and handling instructions. The firm has not ceased distribution. Direct questions about this notification to the Boston Scientific Corporation at 1-510-624-1734.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 94,296 units
- Distribution
- Worldwide Distribution -- United States, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denm
- Date initiated
- 2009-10-06
- Date posted
- 2009-11-20
- Date terminated
- 2011-12-19
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K980453) | Boston Scientific Scimed, Inc. | 1998-08-11 |