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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up."
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…
- Manufacturer
- Lumenis Limited
- Hazard
- Affected units
- 931
Distribution
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