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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 10, 2005
Date Posted April 13, 2005
Recall Status1 Terminated 3 on July 11, 2005
Recall Number Z-0709-05
Recall Event ID 31515
PMA Number P910023 P030054 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product Implantable Cardioverter-Defibrillator

Models affected include the following:

Atlas+ Models V-193, V-193C and V-243
Epic+ Models V-196, V-236 and V-239
Epic Models V-197 and V-233
Atlas Model V-242
Epic HF Models V-337 and V-338
Epic+HF Models V-339 and V-350
Atlas+ HF Models V-340, V-341 and V-343
Code Information Too numerous to include here.
Recalling Firm/
Manufacturer		 St Jude Medical
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
818-463-2587
Manufacturer Reason
for Recall		 Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
FDA Determined
Cause 2		 Other
Action Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
Quantity in Commerce 1488
Distribution Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = Abbott Medical
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