FDA issues recall of intraoperative imaging system due to safety risks

The U.S. Food and Drug Administration has issued a recall of a product used to improve margin visualization during lumpectomy procedures. 

The recall relates to the sterile probe covers used alongside Lumicell’s Direct Visualization System (DVS), which uses a fluorescent optical imaging agent to highlight cancerous margins in real-time during lumpectomies. During the procedure, the elastic bands that hold the probe covers could potentially detach or fracture, according to recall information. 

“As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity, potentially leading to surgical site infections,” the notice reads. 

Approximately 200 units are affected by the recall. These products are distributed throughout California, Florida, Massachusetts, North Carolina and Texas. 

Lumicell issued urgent recall letters to affected customers on July 31. Those messages indicate that the DVS system can still be used without the elastic bands, as they do not affect the device’s performance. Forgoing the bands could result in the secondary sterile probe cover shifting during use but can be repositioned if needed.  

If users do not forego the bands, they will need to follow the DVS use instructions closely and ensure the bands are counted before and after procedures to make sure they are all accounted for. In the meantime, Lumicell is continuing to work on a long-term solution to the issue. 

Affected customers with questions or concerns can contact Lumicell’s customer support team at 833-4-LUM-DVS (Monday through Friday, 9 a.m. to 5 p.m. Eastern Time) or email [email protected]. Lumicell is encouraging customers who have knowledge of adverse events to report said instances to the FDA's MedWatch Adverse Event Reporting program. 

More information on the recall is available here.