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U.S. Department of Health and Human Services

Class 3 Device Recall FastCath" Transseptal Guiding Introducer

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  Class 3 Device Recall FastCath" Transseptal Guiding Introducer see related information
Date Initiated by Firm March 28, 2012
Date Posted December 28, 2012
Recall Status1 Terminated 3 on July 12, 2013
Recall Number Z-0617-2013
Recall Event ID 63855
510(K)Number K964518  
Product Classification Introducer, catheter - Product Code DYB
Product Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343

Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Code Information Model no. 406586 Batch no. 3619533
Recalling Firm/
Manufacturer		 St Jude Medical Inc
177 E County Road B
Saint Paul MN 55117-1951
For Additional Information Contact
651-756-6526
Manufacturer Reason
for Recall		 St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
FDA Determined
Cause 2		 Process control
Action St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526
Quantity in Commerce 26
Distribution US Distribution only including the states of FL, KY and OK.
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 = DYB and Original Applicant = DAIG CORP.
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