Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Covidien Pipeline Embolization Device

24 Dec 2012

Health Canada posted a medical device safety alert concerning pipeline embolization device, manufactured by Covidien LLC.

The manufacturer has discovered that deployment difficulties of the device may occur in procedures where the device is being delivered in areas of significant tortuosity or restrictive anatomy. If significant resistance is encountered during device delivery, difficulties in obtaining full disengagement from the capture coil or incomplete expansion of the device may occur.

For details, please refer to 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 products, please contact your supplier for necessary actions.

Posted on 24 December 2012

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