The U.S. Food and Drug Administration (FDA) recently announced the recall of about 142 Medtronic Rashkind Balloon Septostomy Catheters. The FDA has identified this as a Class I recall, the most serious type of recall, which indicates that the use of these devices may cause…
Medtronic recently announced in an Urgent Medical Device Recall that it was recalling all unused Medtronic Valiant Navion Thoracic Graft Systems around the world. The company informed physicians to immediately cease use of the device until further notice. Medtronic Recalls Graft System After Receiving Reports…
The U.S. Food and Drug Administration (FDA) recently announced the recall of all Boston Scientific LOTUS Edge Aortic Valve Systems. These systems are comprised of two separate parts, one being the valve and the other the delivery system. These devices are used to treat patients…
A Minnesota woman filed a new ParaGard IUD lawsuit on November 6, 2020. The case is pending in the U.S. District Court for the District of Minnesota and involves allegations that the birth control device is defective and dangerous. Plaintiff States ParaGard Broke Into Pieces…
While the NuVasive Magec System—a treatment for child scoliosis—remains on the market in the U.S., it has been banned in the United Kingdom (UK) because of safety concerns. What is the Magec System? Traditional treatment for children with scoliosis (curvature of the spine) involves inserting…
On Feb. 13, 2020, NuVasive Inc. issued a recall of the MAGEC System Model X rods. Used to treat children with early-onset scoliosis, they help brace the spine during growth to minimize the progression of the disease. However, the rods had a higher failure rate…
The FDA recently announced a Class 1 recall—the most serious type of recall—of Ethicon Echelon Flex Endopath surgical staplers. The devices may not work as expected, presenting a risk of serious injuries or even death. The company initiated the recall on October 3, 2019, which…
The Food and Drug Administration (FDA) recently announced that medical company Medtronic is recalling over 106,000 catheters in the U.S. The administration has identified this as a Class I recall, which is the most serious type of recall, and indicates that use of these devices…
Many of today’s advanced medical devices provide the benefits of real-time information to medical professionals. Insulin pumps, defibrillators, and cardiac monitoring devices send data over the Internet, increasing the ability of healthcare providers to monitor and treat their patients to the best of their ability.…
The FDA recently announced a Class I recall of about 25,000 GE Healthcare Giraffe Infant Warmers and Panda i-Res Infant Warmers due to safety concerns. A Class I recall is the most serious type of recall and identifies devices that may cause serious injuries or…
