FDA Issues Alert Regarding Getinge/Maquet Endoscopic Vessel Harvesting Systems

The FDA is alerting healthcare providers and facilities regarding safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems.

Specifically, there is a risk involved with the VasoView HemoPro 1.5 (VH-3500) and VasoView HemoPro1 (VH-3000-W). Silicone may “detach from the jaws of the harvesting tool during use, resulting in the device becoming non-functional and/or silicone debris entering the patient,” which can lead to an “EVH procedural delay and/or conversion of the EVH procedure to a more invasive open vessel harvest procedure.”

To that effect, there have been 17 reports of “serious injury due to silicone debris being introduced to the patients including three instances where the debris was unable to be removed.”

The FDA recommends return of “all unused VasoView HemoPro 1.5 (VH-3500) devices due to risk of silicone detachment.” Since there are limited alternative options, the recommendation is to “inspect the device prior to use for any signs of damage including silicone peeling away from the jaws.”

The recall has been classified as a Class I recall, which is the most serious type. The devices are “designed for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.”