Medical device manufacturer, Edwards Lifesciences LLC issued a safety alert concerning their Swan-Ganz Catheters with model numbers of TS057HF7, 131F7, 131F7J, 131HF7, 131HF7J, 131HV7J, 141F7, 141HF7, 141HF7J, 151F7 and 151HF7 (manufactured between 9 Jan 2012 and 3 May 2012).
The above products are now being recalled as users may have difficulties inserting a J-tip guidewire through the distal lumen hub of the catheter.
Edwards explained that this condition only affects passage of the guidewire when it is being inserted through the distal lumen hub. If the catheter can be placed without guidewire support, it will function and measure pressures as intended. However, the wire will fully advance through the catheter if the back end of the wire is loaded into the distal tip of the catheter.
According to the local supplier, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 30 May 2012