Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210,
FDA device recall Z-0895-06 · posted 2006-05-23 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
- Action taken
- On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 444 units
- Distribution
- The product was released for distribution to 51 consignees in US and 12 foreign consignees: Finland, Austria, Belgium, The Netherlands, Great Britain, Italy, France, Spain, Germany, Poland, Russia and
- Date initiated
- 2006-04-26
- Date posted
- 2006-05-23
- Date terminated
- 2006-12-21
- 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 |
|---|---|---|
| PIVOT STEERABLE MICROCATHETER (K050630) | Boston Scientific - Precision Vascular | 2005-03-22 |