Defective Medical Devices & Implants

After 7 Injuries and 1 Death, Ethicon Recalls Echelon Surgical Staplers

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…

By Eric T. Chaffin

/ 4 Dec 2019

After 7 Injuries and 1 Death, Ethicon Recalls Echelon Surgical Staplers

Medtronic Recalls Over 106,000 Potentially Defective Catheters

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…

By Eric T. Chaffin

/ 9 Nov 2019

Medtronic Recalls Over 106,000 Potentially Defective Catheters

Cybersecurity: Could Your Personal Medical Device be Hacked?

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 o

By Eric T. Chaffin

/ 22 Aug 2019

Cybersecurity: Could Your Personal Medical Device be Hacked?

GE Recalls Infant Warmers After 338 Complaints

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…

By Roopal Luhana

/ 22 Aug 2019

GE Recalls Infant Warmers After 338 Complaints

Number of Ethicon, Bard, and Atrium Mesh Lawsuits Increasing

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 1,00

By Eric T. Chaffin

/ 1 Aug 2019

Number of Ethicon, Bard, and Atrium Mesh Lawsuits Increasing

Health Canada Bans Allergan Textured Breast Implants

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

By Roopal Luhana

/ 2 Jul 2019

Following Ban on Transvaginal Mesh Devices, Panel Discusses Hernia Mesh Safety

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…

By Eric T. Chaffin

/ 27 Jun 2019

FDA Ends “Hidden Reporting” Program for Medical Devices

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…

By Eric T. Chaffin

/ 7 Jun 2019

FDA Ends “Hidden Reporting” Program for Medical Devices

FDA Warns of Battery Problems with Medtronic Pacemakers

The FDA recently warned patients and doctors about a potential problem with certain Medtronic pacemakers. The batteries in these pacemakers may drain more quickly than they should, presenting a danger that the device may not deliver the appropriate pacing therapy. Should that happen, patients who…

By Roopal Luhana

/ 31 May 2019

California Man Suffers Prolonged Pain After Hernia Repair with Parietex Products

A California man has filed a new hernia mesh lawsuit against manufacturer Covidien, L.P., and Medtronic, Inc. He claims that after being implanted with the Covidien Parietex Optimized Composite Mesh and the Covidien Parietex Hydrophilic Anatomical Mesh, he suffered permanent injuries and significant

By Eric T. Chaffin

/ 8 May 2019

California Man Suffers Prolonged Pain After Hernia Repair with Parietex Products

FDA Warns Patients to Avoid Purchasing Pre-Owned Test Strips Online

Individuals with diabetes and some heart conditions are required to check their blood regularly. For example, patients with heart conditions who are taking the blood thinning medication warfarin test their blood to make sure that they are receiving the correct dosage, and to avoid developing…

By Roopal Luhana

/ 22 Apr 2019

FDA Confirms Association Between Breast Implants and Lymphoma

As of September 30, 2018, the FDA had received 660 medical device reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. Though not a form of breast cancer, BIA-ALCL is a cancer of the immune system that starts in the scar tissue…

By Roopal Luhana

/ 21 Mar 2019

FDA Confirms Association Between Breast Implants and Lymphoma