The PhotonBlade device, which won 510(k) clearance from the FDA in August 2016, was in a limited market release that began in March, Invuity said. Customer feedback, gathered to inform improvements to the device, also delivered the unintentional energy release issue “with the potential to cause tissue damage to patients,” the San Francisco-based company said.
“To mitigate the potential for patient injury, the company has elected to initiate a voluntary recall and remove the small number of remaining units from the field. The company expects to begin shipping product again in the 3rd quarter of 2017, after planned product enhancements have been made,” Invuity said.
“During this limited market release, we received extremely positive market feedback on PhotonBlade. However, due to a small number of reports of unintended energy release from the device we have proactively elected to take these steps,” president & CEO Phillip Sawyer added. “This is consistent with our corporate values centering on quality and safety and we are rapidly implementing product improvements in preparation for a full market release.”
Leerink Partners analysts Richard Newitter and Ravi Misra said the recall, although a “disappointment,” isn’t likely to have much of an effect on Invuity’s books.
“From a headline, patient safety and reputation perspective, a recall is not a positive sign for any company and we view the news as a disappointment given IVTY remains very much an execution story following its 2H16 guidance reset. That said, given that this product release was in the early phase with very minimal contribution baked into our estimates, we think the impact to revenue should be minimal and that 2017 rev guidance shouldn’t be at risk,” they wrote this morning in a note to investors.
IVTY shares were off -6.5% to $6.50 apiece today in mid-morning trading.