Cette page Web a été archivée dans le Web

L’information dont il est indiqué qu’elle est archivée est fournie à des fins de référence, de recherche ou de tenue de documents. Elle n’est pas assujettie aux normes Web du gouvernement du Canada et elle n’a pas été modifiée ou mise à jour depuis son archivage. Pour obtenir cette information dans un autre format, veuillez communiquer avec nous.

Rappel de produits de santé

Solarice Rapid Exchange Balloon Dilation Catheter

Starting date:: July 13, 2017
Posting date:: August 15, 2017
Type of communication:: Medical Device Recall
Subcategory:: Medical Device
Hazard classification:: Type II
Source of recall:: Health Canada
Issue:: Medical Devices
Audience:: General Public, Healthcare Professionals, Hospitals
Identification number:: RA-64224

Reason
Affected products

Reason

Medtronic is initiating a voluntary recall on specific lots of Solarice Rapid Exchange Balloon Dilation Catheter due to reports of stylette removal difficulties. In the event that stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. Potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. In addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury.

Affected products