Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters.
FDA device recall Z-1159-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.
- Action taken
- Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 235
- Distribution
- Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.
- Date initiated
- 2007-06-04
- Date posted
- 2007-08-09
- Date terminated
- 2007-12-19
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K964859) | Scimed Life Systems, Inc. | 1997-02-10 |