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…
Many patients have experienced serious complications after being implanted with hernia mesh devices made by Ethicon, Atrium, and C.R. Bard. These include infections, inflammation, migration, and adhesions. Correspondingly, the number of hernia mesh lawsuits continues to increase, with more than 1,000 new ones filed in…
In May 2019, the FDA warned doctors and patients about potential problems linked to textured breast implants. Amy Abernethy, FDA Principal Deputy Commissioner, and Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, released a joint statement in which they acknowledged the…
On April 16, 2019, the FDA ordered all manufacturers of transvaginal mesh devices to stop selling and distributing their products in the U.S. immediately. This was the culmination following a series of actions meant to protect women’s health and was made in response to growing…
When something goes wrong with a medical device, the manufacturer is typically required to report those problems to the Food and Drug Administration (FDA). These reports are then added to a database and made available to the public—unless the manufacturer manages to get an exemption…
