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U.S. Department of Health and Human Services

Class 3 Device Recall Mach 1 6F 3.5 JR curve style Guide Catheter

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 Class 3 Device Recall Mach 1 6F 3.5 JR curve style Guide Cathetersee related information
Date Initiated by FirmMay 24, 2004
Date PostedJanuary 24, 2006
Recall Status1 Terminated 3 on January 23, 2007
Recall NumberZ-0433-06
Recall Event ID 32922
510(K)NumberK010874 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductMach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
Code Information Product UPN H749343566850, Lot # 6287583
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.
FDA Determined
Cause 2		Other
ActionA Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product.
Quantity in Commerce10 devices
DistributionWithin the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
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 = DQY
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