FDA warns of arterial bypass device safety concerns: 5 things to know

The device is primarily used during endoscopic arterial bypass surgeries, according to a Nov. 15 news release from the FDA.

Here are five things to know about the FDA warning:

1. Manufacturer Getinge/Maquet issued a recall notice to providers on Sept. 20, advising them not to use the VasoView HemoPro 1 and 1.5 devices due to the risk of silicone detaching from the device during use.
2. The company received 18 complaints of silicone detachment between April 1 and July 31, with 17 reports of silicone debris detaching inside patients during treatment. There were three reported cases of providers being unable to remove the debris.
3. The FDA is evaluating reports of silicone detachment with VasoView HemoPro 2 devices.
4. Due to the recall and limited alternative device options, the FDA has added endoscopic vessel harvesting devices to the medical device shortage list.
5. The FDA warning includes guidance and recommendations for risk mitigation if providers are unable to find alternative devices for use.

Read the full FDA warning here. 

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