Medical Devices & Implants

Following the Exactech knee and ankle joint replacement system recall announced in February 2022, Exactech promised to send out recall letters to affected patients. Yet tens of thousands of individuals who received the recalled implants have yet to receive notification of the recall. Many may…

The U.S. Food and Drug Administration (FDA) recently announced the recall of about 3,000 Imperative Care Zoom 71 Reperfusion Catheters. These are used to remove blood clots in the brain of a patient within eight hours of an acute ischemic stroke caused by blocked or…

The U.S. Food and Drug Administration (FDA) recently announced a Class I recall—the most serious type of recall—of  126 Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoirs with Balance Biosurfaces because of possible high levels of endotoxins. Using these devices could cause serious injuries or death.…

The U.S. Food and Drug Administration (FDA) recently announced the Class I recall—the most serious type—of 157 Medtronic HVAD Pump Implant Kits for the HeartWare HVAD System. Doctors use these devices in patients needing heart transplants to help the heart continue to pump blood to…

A Pennsylvania woman recently filed a new Medtronic lawsuit in the U.S. District Court for the Middle District of Pennsylvania. She claims that after using the Medtronic MiniMed insulin pump, she suffered from serious injuries. She seeks compensatory and punitive damages. Plaintiff Suffers Low Blood…

The U.S. Food and Drug Administration (FDA) recently announced a Class I recall—the most serious type of recall—for all lots of Ovation iX Abdominal Stent Graft Systems. Though manufacturer Endologix Inc. initially told their customers that the problems with the devices were due to incorrect…