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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Wiseguide Guide Catheter

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  Class 2 Device Recall Boston Scientific Wiseguide Guide Catheter see related information
Date Initiated by Firm May 22, 2006
Date Posted June 10, 2006
Recall Status1 Terminated 3 on December 30, 2006
Recall Number Z-1102-06
Recall Event ID 35515
510(K)Number K974684  
Product Classification Guide Catheter - Product Code DQY
Product Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
Code Information Catalog number 19500-448, Lot # 655713; Catalog number 19500-498, Lot # 655721; Catalog number 19500-08, Lot # 657310; Catalog number 19500-09, Lot # 657311; Catalog number 19500-132, Lot # 655680; Catalog number 19500-27, Lot # 655695;
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
FDA Determined
Cause 2		 Other
Action Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.
Quantity in Commerce 75
Distribution Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
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 = DQY and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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