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U.S. Department of Health and Human Services

Class 2 Device Recall Impulse Angiographic Catheter

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 Class 2 Recall
Impulse Angiographic Catheter
see related information
Date Posted January 31, 2008
Recall Status1 Terminated on October 23, 2008
Recall Number Z-0937-2008
Recall Event ID 45903
Premarket Notification
510(K) Numbers
K000956  K964859  K974559  K992123 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.
Code Information Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. : 16599-04/H74916599042/H74916599040/0020033644; and 16599-04/H74916599042/H74916599040/0020036932.
Recalling Firm/
Manufacturer
Boston Scientific
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
Manufacturer Reason
for Recall
Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****.
Quantity in Commerce 211 total single units
Distribution Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
510(K)s with Product Code = DQO and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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