(800) 369-0899
(215) 569-4000

Contact Us Today



← Older posts Newer posts →

FDA Recalls HeartMate 3 LV Assist Device

In May 2018, less than a year after approval, the Federal Food and Drug Administration (FDA) issued a Class I recall on HeartMate 3, a medical device which is inserted into patients to treat heart failure. The device assists in pumping blood in the left ventricle of the heart of patents who are at risk » Read More

Essure Complications and Medical Device Lawsuits

In 2002, the Federal Food and Drug Administration (FDA) approved Essure. Essure was designed as a medical device to prevent pregnancies in women. Women are inserted with two of the devices, which resemble a coil, one in each fallopian tube, to assist the body in creating a natural blockage in the tubes in order to » Read More

Unsecured Medical Devices and Hospital Computer Security Risks

Clinicians are able to deliver more efficient patient care with connected devices and remote monitoring. Constant monitoring and telemedicine have been proven beneficial in determining causes of illnesses for patients. However, when devices, medical or non-medical, are equipped with connectivity and sensors, security risks and vulnerabilities are typically identified and uncovered. Medtronic, Boston Scientific, and » Read More

FDA’s Medical Device Safety Action Plan

The Food and Drug Administration (FDA) regulates over 190,000 different medical devices, made by more than 18,000 firms in more than 21,000 facilities worldwide. Many Americans today depend on a medical device in order to maintain their health. Pacemakers, insulin monitors, and heart valves are all commonly used medical devices. The agency’s oversight obligations include » Read More

The How and Why of Medical Device Recalls

Have you ever wondered how and why medical devices get recalled?  The Food and Drug Administration (FDA) regulates approvals and recalls for food, drugs, and medical devices.  While the FDA must be provided with reasonable assurances that every medical device it approves for use is safe and effective, sometimes problems arise. What is the Basis » Read More

Medtronic Recalls Defective Defibrillators

On January 22, 2018, the US Food and Drug Administration (FDA) issued a Class I recall of a group of cardiac defibrillators.  These defective medical devices, manufactured by Medtronic, include their Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs). The FDA has identified this as a Class I recall, which is the most » Read More

Hernia Repair Mesh Problems

Surgeons increasingly rely on meshes, which are medical devices that are surgically implanted into a patient. A mesh is made from one or more sterile non-absorbent plastic materials. It serves as a prosthesis to support failing tissue, acting as a matrix or platform where normal tissue can grow. These medical devices require approval by the » Read More

Attune Knee Replacement Failures

Individuals suffering from chronic knee pain and immobility have turned to artificial knee replacements to regain an active lifestyle. Artificial knee replacement surgery can help a patient increase the range of motion in their knees and regain the use of their muscles and ligaments. DePuy Synthes’s Attune Knee Replacement System, a Johnson & Johnson product » Read More

Faulty Lead Poisoning Test Recall

In May 2017, the United States Food and Drug Administration issued a medical device recall of a lead poisoning test that had been administered to up to seven million children between 2014 and 2017. The tests, according to the Centers for Disease Control and Prevention, failed in a way that caused them to provide inaccurately » Read More

BioMimics and Medical Device Testing

Continuous recalls of defective medical devices have prompted new research in medical device testing. To improve the quality and safety of medical devices, the 3D printing company, Stratasys, has designed a new tool for device testing. BioMimics consists of fully functional, 3D printed models that replicate the human body. Instead of turning to animals, mannequins, » Read More

← Older posts Newer posts →