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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

First Digital Pill to Track Patient Medication

The Food and Drug Administration has approved a digital pill capable of tracking whether patients are taking their medication. The pill, which will become available to patients in 2018, includes a minute digital sensor that records when patients take the drug. Currently, the approval is strictly for Abilify MyCite, a medication approved for schizophrenia or » Read More

Recall of Johnson and Johnson Valve Replacements

The Food and Drug Administration (FDA) started 2018 with a Class 1 recall of heart valve replacement devices. A Class 1 recall is the highest level of recall issued by the FDA. It is issued when there is a reasonable probability that a device could cause serious health issues, including death. Cost of Device Failure » Read More

Heart Stents Fail to Ease Chest Pain

Since Robert A. Ersek, M.D. patented the first heart stent in 1972, the procedure has become a common practice in hospitals around the world. Hundreds of thousands of patients annually undergo a surgical procedure that includes inserting a stent into an artery. However, new research indicates that some of these patients may have undergone this » Read More

Reducing the Risk of Medical Device Recalls

Reducing the risk of medical device recalls might be as simple as increasing the rotations of FDA plant inspectors. This was the key finding from a study that sampled seven years of data from FDA inspections and recalls. If the FDA decides to implement the findings, researchers believe it will lead to higher quality facilities » Read More

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