The U.S. Food and Drug Administration (FDA) posted a letter to health care providers on Nov. 15, announcing that Getinge/Maquet has issued an Urgent Medical Device Removal notice warning against use of the VasoView HemoPro 1.5 (VH-3500) and VasoView HemoPro 1 (VH-3000-W, marketed only outside the U.S) due to “risk that silicone may detach from the jaws of the harvesting tool during use.”

With the removal of VasoView HemoPro 1.5 devices from use, the FDA has included endoscopic vessel harvesting devices on the medical device shortage list. There is an ongoing evaluation of reports of silicone detachment with VasoView HemoPro 2 (VH-4000 and VH-4001) devices.

Access additional information and FDA recommendations here.

Keywords: United States Food and Drug Administration, ACC Advocacy, Endoscopy