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U.S. Department of Health and Human Services

Class 2 Device Recall Mach 1 Guide Catheter

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  Class 2 Device Recall Mach 1 Guide Catheter see related information
Date Initiated by Firm December 13, 2006
Date Posted February 07, 2007
Recall Status1 Terminated 3 on June 28, 2007
Recall Number Z-0384-2007
Recall Event ID 37001
510(K)Number K020028  
Product Classification vascular guide catheter - Product Code DQY
Product Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
Code Information Batch / Lot # 687654
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
FDA Determined
Cause 2		 Other
Action An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.
Quantity in Commerce 7
Distribution Nationwide.
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 = BOSTON SCIENTIFIC
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