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
FDA Recall Z-0895-06 · Posted 2006-05-23
Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeKRA
Date Initiated2006-04-26
Date Terminated2006-12-21
Product Quantity444 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.