The FDA has classified the recall of Getinge/Maquet VasoView HemoPro 1.5 Endoscopic Vessel Harvesting (EVH) Systems as Class I, citing risks of silicone detachment during use. The recall affects model VH-3500 in the U.S. and VH-3000-W internationally.
Between April and July 2024, 18 complaints of silicone detachment were reported. Seventeen cases involved serious injury, with three instances where silicone debris could not be removed. On November 15, 2024, the FDA added EVH devices to the medical device shortage list, as the removal of these devices disrupts supply. The FDA is also evaluating reports of similar issues with VasoView HemoPro 2 devices (models VH-4000 and VH-4001).
Device Complications:
- Silicone detachment
- Device failure during use
- Conversion to open vessel harvesting
- Procedural delays
FDA Recommendations:
- Inspect devices pre- and post-procedure for damage or silicone peeling.
- Monitor devices intraoperatively for detachment.
- Use FDA-cleared alternatives where possible.
- Report adverse events via FDA’s MedWatch program.
The FDA is collaborating with Getinge/Maquet and other manufacturers to address safety concerns and ensure availability of alternative EVH systems. The devices are primarily used for minimally invasive arterial bypass surgeries.
Reference: U.S. Food and Drug Administration. Safety and availability concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems—Letter to Health Care Providers. FDA. Published November 15, 2024. Accessed November 15, 2024. https://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-availability-concerns-vasoview-hemopro-endoscopic-vessel-harvesting-systems-letter-health
