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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT)

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  Class 2 Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT) see related information
Date Initiated by Firm June 01, 2006
Date Posted June 24, 2006
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-1165-06
Recall Event ID 35616
510(K)Number K053217  K053217  
Product Classification Catheter, Percutaneous - Product Code DQY
Product CPS Valve Bypass Tool (VBT), Model 410192
Code Information All lots with a manufacturing date of May 30, 2006 or earlier
Recalling Firm/
Manufacturer
St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
818-493-2587
Manufacturer Reason
for Recall
Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
FDA Determined
Cause 2
Other
Action The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.
Quantity in Commerce 775
Distribution Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
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 = DQY and Original Applicant = ST. JUDE MEDICAL
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