FDA Class I Recall For Lumenis VersaCut Tissue Morcellator

In short

Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the  potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. The FDA has decided that this product may cause serious adverse health consequences, including death, so has slapped a Class I status on the recall.

Background

Morcellators, as the name suggests, are devices that break up and remove dissected tissue during surgical procedures when access to the surgical site is limited, for example during laparoscopy.

The FDA recall notice can be found here.

On Jan. 2, 2013, Lumenis sent an Urgent Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the device with the two labels provided, remove and destroy the existing Operator’s Manual and replace it with a newly supplied current revised Manual, complete and return the information requested on a confirmation card provided.
Source: FDA