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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Atakr

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  Class 2 Device Recall Medtronic Atakr see related information
Date Initiated by Firm November 25, 2002
Date Posted March 06, 2003
Recall Status1 Terminated 3 on November 04, 2003
Recall Number Z-0618-03
Recall Event ID 25111
Product Classification Catheter, Percutaneous - Product Code DQY
Product Atakr II RF Power Generator, Models 4802 and 4803
Code Information All units
Recalling Firm/
Manufacturer		 Medtronic,Inc/Rice Creek Facil
7000 Central Ave N.E.
Fridley MN 55432
Manufacturer Reason
for Recall		 An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
FDA Determined
Cause 2		 Other
Action An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.
Quantity in Commerce 775 units
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.
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