Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
According to a news release issued by the U.S. Food and Drug Administration (FDA), Abiomed has recalled specific Impella 5.5 with SmartAssist for purge fluid leaks that can cause pump stop and loss of support. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Source: dicardiology.com