On January 29th, the FDA revised Penumbra’s Urgent Voluntary Recall of the Jet 7 Catheters with Distal Tip. The FDA has received over 200 reports of adverse reactions to their Medical Device Reporting system (MDRs) including death, serious injury and malfunctions. Serious injuries have been described as vessel damage, hemorrhage, […]
Other Medical Devices
5 posts
By Brittany Mierzwa – FDA Press Release January 12th 2021 – The FDA has published their Action Plan as they move forward with Artificial Intelligence/Machine Learning (AI/ML) -based software as a Medical Device. The FDA’s vision through AI/ML -based software ‘will deliver safe and effective software functionality that improves the […]
By Shelley Blas May 18, 2012 – A new study, published earlier this week in the British Medical Journal shows that NuvaRing carries a higher risk of blood clots than combined oral contraceptives (COCs) based on oestrogens and progestins. Women who used the vaginal ring or transdermal patches had around […]
Original article by Richard Knox, NPR March 19, 2012 – Because older-model artificial hips are usually made of a tough plastic and metal, they can wear out, especially in people who are physically active. Manufacturers of all-metal hips have touted them as the right choice for younger patients but, for […]
Posted April 19, 2010 by Cindy L. Nations DePuy Orthopedics, a subsidiary of Johnson & Johnson, announced a global recall of the following hip implants on August 24, 2010: ASR™ XL Acetabular System ASR™ Hip Resurfacing System The devices were recalled because of a design defect that causes metallic ions […]