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U.S. Department of Health and Human Services

Class 2 Device Recall Pivot

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  Class 2 Device Recall Pivot see related information
Date Initiated by Firm April 26, 2006
Date Posted May 23, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-0895-06
Recall Event ID 35301
510(K)Number K050630  
Product Classification Catheter, Continuous Flush - Product Code KRA
Product 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
Code Information All codes.
Recalling Firm/
Manufacturer		 Boston Scientific Target
4701 Lakeview Blvd
Fremont CA 94537
For Additional Information Contact Irene Jaworski
510-624-1580
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BOSTON SCIENTIFIC - PRECISION VASCULAR
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