In The News

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...

The Medical Devices Behind COVID-19 Testing

Whether surfing the internet, looking at Instagram or watching television, everywhere you look there is talk about COVID-19.  A lot of the conversation about COVID-19 centers on the medical devices used for testing.  From early on in the pandemic, medical device manufacturers have focused on better tests, better testing methods...

FDA Announces More Metformin Recalls Due to Carcinogen

The U.S. Food and Drug Administration (FDA) has announced more Metformin recalls due to potential contamination with the carcinogen N-Nitrosodimethylamine (NDMA).  The latest recall is the fifth involving extended-release Metformin tablets.  For consumers who rely on Metformin to manage their Type 2 diabetes, Metformin recalls are reasonably concerning.  Here is...

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...

Lawsuits Surge Against Surgical Stapler Manufacturers

Lawsuits against surgical stapler manufacturers are surging, according to recent news.  In 2019, surgical staplers made headlines due to recalls and adverse events reports that came to light after years of being hidden in a “secret database.” In June 2019, the U.S. Food and Drug Administration (FDA) released six million...

Another Heartburn Medication Recall Due to NDMA Concerns

Following on the heels of massive Zantac and other heartburn medication recalls, yet another medication is being recalled due to concerns about NDMA (N-Nitrosodimethylamine).  The U.S. Food and Drug Administration (FDA) announced a recall of certain lots of Amneal Pharmaceuticals, LLC Nizatidine Oral Solution.  Here is what we know about...