Lumenis, a medical device manufacturer based in Yokneam, Israel, received Class I recall status from the United States Food and Drug Administration for its Versacut morcellator. According to information from the FDA, the device poses a risk of patient injury or death.

A morcellator is used during laparoscopic procedures to remove large portions of a patient’s soft tissue. The issue with the company’s device is based on labeling.

In the FDA Class I recall notice, the government watchdog agency stated, "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.”

On January 2nd of this year, Lumenis sent out a warning letter to all impacted customers. The warning letter stated that customers should take all affected VersaCut morcellators out of use and carry out a series of simple steps to fix them. These steps included the removal of old labels and remarking the devices with new labels provided by the company. In addition, the company provided customers with new replacement manuals for the affected devices.

VersaCut morcellators that were still on store shelves were quarantined. These units will be relabeled and repackaged by the company for distribution in the future.

References

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340943.htm