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Defective Medical Devices Archives

Partner Post: Medtronic Issues Recall for Defective Guidewires

Medtronic Orders Recall of Dangerous Defective Medical Devices Written by James P. Nevin The Food and Drug Administration has classified the recall of "some Medtronic devices used during heart procedures" as Class I, a category reserved for products with reasonable potential to cause serious injury or death. An estimated 15,000...

Partner Post: Problems with Robotic Surgery

Unreported Injuries Caused by Robotic Surgery Complications  Written by James P. Nevin   Robot-assisted surgery may surprisingly be more dangerous than traditional surgery techniques. The problem is that the FDA does not know absolutely either way because injuries and deaths from using the da Vinci Robotic System are going underreported...

Raising the MICRA Cap to Account for Inflation

In the past few weeks, you might have noticed our social network updates focusing on the battle to reform California's Medical Injury Compensation Reform Act (MICRA). Since 1975 in California, non-economic damages in medical malpractice claims have been capped at $250,000 thanks to MICRA. This amount may have seemed extraordinary...

Post-Approval Studies May Reveal Safety Problems

FDA Creates Web Page Concerning Post-Approval Testing of Medical Devices WASHINGTON, DC -- April 13, 2007 -- The Food and Drug Administration (FDA) has created a new web page that shows the status of recently approved medical devices. Medical devices include heart defibrillators, pacemakers, breast implants, stents, and even hip...

Heart Device Fails to Prevent Pulmonary Embolism

Boston Scientific Pulls Its Heart Device Off the Market NATICK, MA -- December 9, 2005 -- Boston Scientific is recalling its vena cava filter, a heart device designed to prevent pulmonary embolism or blood clots that travel to the lungs (Press Release, December 2, 2005). The device can malfunction when...