The FDA slapped the recall of the Lumenis VersaCut tissue morcellator with Class I status, denoting a device that can cause serious injury or death.
Morcellators are used to cut and remove large masses of tissue during laparoscopic procedures. Yokneam, Israel-based Lumenis is pulling the devices due to a labeling problem that could lead to "serious adverse health consequences, including death," according to the FDA.
"Lumenis Ltd. is recalling certain models of VersaCut morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing," according to the federal watchdog agency.
Lumenis sent a letter Jan. 2 to affected customers, instructing them to take any VersaCut devices affected by the recall out of use and carry out a series of steps. Those include re-marking them with new, Lumenis-provided labels and destroying the obsolete owners manuals and replacing them with the new versions.
The company quarantined the affected products still on its shelves and plans to re-label them and its owner’s manual to remove the risk, the FDA said.