Lumenis VersaCut Recall: Mislabeling Could Lead to Air Embolism

Recent problems with the warnings and instructions provided on a medical device used to remove tissue during surgery, which could cause an air embolism if the tubing is hooked up backwards, has been categories as a Class I recall due to the serious risk of severe adverse health consequences or death. 

The FDA determined on Monday that an “Urgent Safety Advisory Notice” sent out last month by Lumenis Limited regarding the VersaCut Tissue Morcellator constitutes the most serious category of medical device recalls, involving situations where continued use of the product poses a reasonable probability of death or severe injury.

The Lumenis VersaCut Tissue Morcellator recall was posted on the FDA website on February 25, after the manufacturer re-labeled the product on January 2, due to a risk of users hooking up the aspiration tubing backwards to the aspiration control box.

The recalled Lumenis VersaCut Tissue Morcellator products are used to break up and remove tissue during surgeries where access to the surgical area is limited. Because of inaccurate instructions the devices may be assembled backwards, potentially causing air embolisms to occur during surgery.

The recall affects the VersaCut Morcellator starter kit with model number 0637-245-01 and control box with model number 0636-470-01. All VersaCuts manufactured by Lumenis Limited since May 1998 are included.

In the letter sent out by the manufacturer on January 2, customers were directed to re-label the device with two new warnings provided and to replace the Operator’s manual with a revised copy. Customers were also asked to return a confirmation card to verify that the steps were taken.

The FDA has indicated that the Lumenis VersaCut should be quarantined and use should be discontinued until the Operator’s Manual has been replaced or fixed. Consumers may submit reports online at www.fda.gov/MedWatch/report.htm or call 1-800-332-1088 top request a reporting form. For further questions regarding the devices consumers may contact VersaCut Morcellator field correction administrator at +972-(54)-9599196 or +972-(4)-9599296 or via email at VersaCutMorcellator@lumenis.com