The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. This agency also oversees the regulation and safety of many food items and cosmetic products. Below are recent FDA recalls and notifications concerning the safety of medical devices and drugs.
Impella Blood Pumps
The FDA has issued a Class I recall of Impella Left Sided Blood Pumps manufactured by Abiomed. These life-saving pumps are used to support the heart after traumatic events such as heart attacks or open heart surgeries. Additionally, they may be used when the heart does not function well.
The recall was initiated after Abiomed realized the pump catheter may perforate the wall of the heart. This can result in serious injury such as ventricle perforation, rupture, hypertention, blood flow problems, or even death. There have been over 100 reports of adverse events. Unfortunately, there have been approximately fifty reports of deaths. The devices were distributed between October 2021 and October 2023.
The recall is a Class I recall. Class I recalls are the most serious type of recall, and are reserved for medical devices that may cause serious injury or death. The full recall announcement can be found here.
Over The Counter Topical Pain Relief Products
The FDA is warning consumers not to use certain over the counter topical pain relief products. Several different companies manufacture the products. The products are marketed to relieve pain before or after minor cosmetic procedures such as laser hair removal and tattooing.
Consumers are urged not to use the products because they are marketed in violation of Federal law. Specifically, they contain ingredients that exceed the amount allowed by the FDA.
For instance, some of the products contain excessive amounts of lidocaine Absorption of high concentrations of lidocaine may lead to adverse events such as irregular heartbeat, seizures, or breathing problems. Importantly, the products containing elevated concentrations of lidocaine may interact with necessary medications or important dietary supplements.
The recalled products are available in stores and online. Products subject to the recent warning can be found on the FDA’s website. The FDA stresses that there is no evidence these products are safe.
If you have been injured by one of the aforementioned products, please contact the FDA.
