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U.S. Department of Health and Human Services

Class 2 Device Recall St Jude Medica CPS Direct SL

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  Class 2 Device Recall St Jude Medica CPS Direct SL see related information
Date Initiated by Firm March 20, 2007
Date Posted June 14, 2007
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0933-2007
Recall Event ID 37818
510(K)Number K053277  
Product Classification Slittable CRT lead delivery tool - Product Code MCX
Product St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
Code Information Models: CPS Direct SL (Models 410110; 410111; 410112; 410113; 410114; 410115; 410116; 410120; 410121; 410122; 410123; 410124; 410126).  CODE INFORMATION: All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
Recalling Firm/
St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
Manufacturer Reason
for Recall
Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
FDA Determined
Cause 2
Action By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves. The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.
Quantity in Commerce 14,000
Distribution Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.
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 = MCX and Original Applicant = ST. JUDE MEDICAL