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U.S. Department of Health and Human Services

Class 2 Device Recall Epic HF Model V350

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  Class 2 Device Recall Epic HF Model V350 see related information
Date Initiated by Firm January 16, 2008
Date Posted August 19, 2008
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-1329-2008
Recall Event ID 46870
PMA Number P030054 P910023 
Product Implantable Cardioverter Defibrillator
EPIC + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-350
Code Information all serial codes
Recalling Firm/
Manufacturer		 St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
818-362-6822
Manufacturer Reason
for Recall		 A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
FDA Determined
Cause 2		 Software design
Action A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
Distribution Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
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.
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