Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections
Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (air embolism) where injury has been reported, but the agency classification is Class I (unlikely to cause adverse health consequences) and the primary action is corrective labeling.
Plain-English summary
Lumenis Limited is recalling 931 units of the VersaCut Tissue Morcellator to perform corrective labeling. The recall is being conducted in response to three reported events of air embolism that occurred secondary to incorrect reversal tubing system hook-up.
The affected products include Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box), which includes all products since the initial product release in 1998. The devices are intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during various surgical procedures.
The recall covers worldwide distribution, including the United States and numerous international locations. The source text does not specify specific actions for consumers or healthcare providers beyond the corrective labeling.
The recalled product
- Product
- The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgi
- Manufacturer
- Lumenis Limited
- Hazard
- Affected units
- 931
Distribution
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