Medtronic Heart Pump Recall Follows Patient Death

Medical device manufacturer Medtronic is recalling certain HeartWare Ventricular Assist System (HVAD) heart pumps due to the possibility of an interruption in the electrical connection between the power source and HVAD controller.  The U.S. Food and Drug Administration (FDA) is classifying this recall as a Class I, which is the...

FDA Issues Class I Recall of Latex Balloon Catheters

The U.S. Food and Drug Administration (FDA) has designated a recall of Applied Medical latex balloon catheters as a Class I recall.  This is the most serious medical device recall designation, meaning that there is a, “Reasonable probability that using the product will result in serious adverse health consequences or...

FDA Issues Multiple Safety Alerts for Medical Devices

The U.S. Food and Drug Administration (FDA) issues recalls and safety alerts to keep consumers and the healthcare community informed.  Safety alerts often involve drugs, medical devices, supplements and cosmetics.  In September, the FDA issued multiple new safety alerts for medical devices and drugs.  Several of the safety alerts involve...

FDA Recalls Textured Breast Implants over Cancer Concerns

In July, 2019, the U.S. Food and Drug Administration (FDA) requested that Pharmaceutical manufacturer, Allergan, recall certain textured breast implants.  FDA recalls like this one highlight ongoing concerns about breast implants and resulting illnesses.  It also continues the discussion about whether a warning or a medical device recall is more...