Medical device manufacturer and distributor, Cook Medical, has issued a medical device safety alert concerning its pericardiocentesis and thoracentesis catheter. The affected devices are identified as the following:
The manufacturer is initiating a voluntary recall of 12 pericardiocentesis and thoracentesis catheter lots. The catheters are designed to be used with a 0.038" wire guide and the manufacturer has identified that the affected products may have been manufactured with the catheter distal end hole too small.
According to the manufacturer, potential adverse events that may occur if an affected product is used include a delay in the procedure, prolonged procedure, and additional intervention. It is possible that organ or vessel injury could occur during manipulation of the catheter and/or wire guide when attempting to remove the wire guide from the catheter.
Affected users are advised to examine their inventory immediately to determine if they have the affected product(s), and quarantine the affected product(s). They should immediately cease all distribution and use of these products.
Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 10 April 2019.