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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 17, 2005
Date PostedJuly 19, 2005
Recall Status1 Terminated 3 on March 26, 2012
Recall NumberZ-1017-05
Recall Event ID 32465
PMA NumberP910023/S77 P030054/S7 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
ProductImplantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).
Code Information No serial numbers were given. All models mentioned are affected.
Recalling Firm/
Manufacturer		 St Jude Medical
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information ContactNestor Kusnierz
818-362-6822
Manufacturer Reason
for Recall		Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.
FDA Determined
Cause 2		Other
ActionRecall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.
Quantity in Commerce30,000 domestically, 11,684 internationally
DistributionNationwide and Sweden, Canada, Australia, New Zealand. South America and Asia
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = NIK
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