Recall Z-0895-06 ยท KRA Catheter, Continuous Flush
Boston Scientific Target
Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Orton Cir. West Valley City, UT 84119
| Date | May 23, 2006 (initiated Apr 26, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 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 Hong Kong. There were no shipments to U.S. Government facilities or Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050630 | PIVOT STEERABLE MICROCATHETER Boston Scientific - Precision Vascular, Mar 22, 2005 |