Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pivot

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Pivotsee related information
Date Initiated by FirmApril 26, 2006
Date PostedMay 23, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall NumberZ-0895-06
Recall Event ID 35301
510(K)NumberK050630 
Product Classification Catheter, Continuous Flush - Product Code KRA
ProductBoston 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.
FEI Number 2939204
Recalling Firm/
Manufacturer		 Boston Scientific Target
4701 Lakeview Blvd
Fremont CA 94537
For Additional Information ContactIrene 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
ActionOn 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 Commerce444 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = KRA
-
-