Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to alert providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices.
On September 20, 2024, Getinge/Maquet announced a voluntary recall for removal of all unused VasoView HemoPro 1.5 devices due to the risk of silicone detaching from the jaws of the harvesting tool during use. The FDA is aware that the removal of VasoView HemoPro 1.5 from use may interrupt the supply of EVH devices. The FDA has updated the medical device shortage list to include EVH devices (product code GEI).
In addition, the FDA is working with the manufacturer to evaluate reports of silicone detachment with VasoView HemoPro 2 devices.
Acknowledging that alternative options are limited, the FDA is providing recommendations for health care providers and facilities who continue using VasoView Hemopro devices while the FDA evaluation of potential safety concerns with VasoView HemoPro 2 devices and supply concern for EVH devices is ongoing.
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The Letter to Health Care Providers includes important information about this issue, including:
- Information on affected products
- Recommendations for health care providers and facilities
- Actions that the FDA is taking to address the issue
- Instructions for reporting problems with a device
Questions?
If you have questions, contact the Division of Industry and Consumer Education (DICE).