The Health Canada has posted a medical device safety alert concerning Bipolar Temporary Myocardial Heartwire (Model no.: TME 64-S; Lot/Serial no.: C1-07056) manufactured by Oscor Inc.
According to the Health Canada, spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). The defect affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised.
For details, please refer to the Health Canada website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_oct-dec_2012-eng.php
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 28 November 2012