Smartassist System News Today

The FDA issued recalls for several medications and devices, including certain digoxin tablets, intra-aortic balloon pumps, and catheters.

The warning letter is the latest indication of the fresh scrutiny the FDA is paying to software tools and decision aids.

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines and other products, including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

Here are the 10 most recent FDA safety recalls for drugs and medical devices. Several may cause injury or even death if used despite the FDA warnings.

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.

The Impella 5.5 with SmartAssist system is being recalled because of the risk of purge fluid leakage. The company reports 179 complaints, three injuries, and no deaths related to the problem.