Two types of catheter models produced by Abbott Laboratories were recently recalled due to potentially severe safety issues. The two catheters are the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter. The United States Food and Drug Administration (FDA) defined them as Class I recalls, which is the most serious » Read More
According to the U.S. Food and Drug Administration (FDA), Medtronic insulin pumps are facing a recall due to a flood of over 26,000 reported malfunctions. The malfunction led to thousands of injuries and at least one death. Ultimately, Medtronic is recalling over 300,000 insulin pumps as part of the Class I recall. Affected products include » Read More
Medical devices have come a long way in making patients’ lives more convenient. However, there have also been many issues with medical devices that have led to patients suffering injuries and even death. According to the U.S Food and Drug Administration (FDA), there have been over five million reports of failed medical devices in the » Read More
Code rot, also known as software rot, is when software deteriorates over time due to a variety of internal factors. Code rot implies that a device’s software is no longer stable or reliable. This instability poses a threat to individuals who use medical devices that rely on software to perform accurately. Unfortunately, code rot can » Read More
Pacemakers are literal lifesavers. However, JAMA Internal Medicine reports that improvements in the safety surveillance systems surrounding cardiac devices are necessary to protect patients from pacemaker failures. In a recent editorial, a resident at the University of California, San Francisco and a professor of medicine at University of California, San Francisco wrote that progress on » Read More
Medical device recalls are a way for manufacturers to remove a device that is not deemed safe by the Food and Drug Administration (FDA). Staying informed about medical device recalls is important for users, since the recall might indicate that a medical device can cause injury or death. What is a Recall? A medical device » Read More
Every year, the Food and Drug Administration (FDA), as well as other companies, issue medical device and medication recalls that affect millions of patients. Although efforts are made to contact patients and providers, there are cases where the recall messages do not reach those who need to receive it. There has been a slew of » Read More
Doctors routinely use the latest equipment and protocols to help patients suffering from a wide variety of diseases and conditions. However, sometimes products are brought to market before their manufacturers thoroughly investigate all possible defects or problems. In those situations, issues usually arise after the items have already been applied to medical procedures, which can » Read More
Medical device manufacturers may not always have complete control over how their products are manufactured. From inception to delivery, there are third parties involved in the process. This can allow room for problems that can result in poor quality and defective devices; patients that use them can end up with serious or fatal results. There » Read More
Patients that must use medical devices to stay healthy put their trust in this equipment and the companies that manufacture them. Stents, implants, and insulin pumps are just a few examples of devices that have helped people over the years. It is impossible to count how many lives have been saved by medical devices, but » Read More