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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Fort

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  Class 2 Device Recall Boston Scientific Fort see related information
Date Initiated by Firm May 12, 2009
Date Posted June 24, 2009
Recall Status1 Terminated 3 on December 11, 2011
Recall Number Z-1486-2009
Recall Event ID 52098
510(K)Number K011968  
Product Classification intravascular guide wire - Product Code DQX
Product Boston Scientific Fort¿¿ Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
Code Information W2405148
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer Reason
for Recall		 Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the
FDA Determined
Cause 2		 Process control
Action Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form.
Quantity in Commerce Total of 5 boxes (5 units /box) ,
Distribution USA distribution: AR, MO, CA, FL, and NV.
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 = DQX and Original Applicant = LAKE REGION MFG., INC.
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