| Class 2 Device Recall Mach 1 Guide Catheter | |
Date Initiated by Firm | December 13, 2006 |
Date Posted | February 07, 2007 |
Recall Status1 |
Terminated 3 on June 28, 2007 |
Recall Number | Z-0383-2007 |
Recall Event ID |
37001 |
510(K)Number | K010874 |
Product Classification |
vascular guide catheter - Product Code DQY
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Product | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX. |
Code Information |
Batch / Lot #: 687586, 687593, 687596 |
Recalling Firm/ Manufacturer |
Boston Scientific 1 Scimed Pl Maple Grove MN 55311-1565
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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 | 9 |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQY
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