Medical devices often perform life-or-death functions for the patients who rely on them. Given how important reliable functioning is in a device that might regulate someone’s health and well-being, medical devices are subject to testing and should meet strict standards regarding performance and durability.
Unfortunately, the companies that produce medical devices sometimes release units to the public that are unsafe. There may be an issue with the design itself that they didn’t realize until many people began using the device. There could also be a production issue that makes certain batches of a medical device less reliable than others.
Medical device recalls are some of the most serious recalls that take place. They can result in thousands of dollars of financial costs and losses for those dealing with a defective device. A recent medical device recall is a perfect example of how serious such recalls can be.
Devices supporting heart function must be reliable
When people require heart implants, they need those devices to perform perfectly. Failure could mean death for users. Concern about fatal risks made the Medtronic HVAD Pump Implant Kit the focus of a new Class I recall. As far as the recalls organized by the Food and Drug Administration (FDA) go, this type of recall is the most serious. A Class I recall means that using the product could result in severe injury or even death.
Units labeled as PUMP 1103, 1104 or 1104JP distributed between October 24, 2017 and April 30, 2020 could be part of the recall, which started last November. There are 157 units recalled, and many of those were already surgically installed in the patient with a heart issue.
At least two people have died and dozens more have been injured because their device failed to start. The device could also delay restarting – an issue that could cause a heart attack. It could exacerbate heart failure issues and even lead to someone’s death.
What does this recall mean for patients?
Someone who received a defective implant may have to have emergency surgery to replace the device. Surgery can cost thousands of dollars, as can the lost wages a person incurs during their recovery. Going through a second operation is not without its risks. It can put a lot of strain on the body and might result in secondary consequences, or even death, for the patient.
Those experiencing adverse effects because of defective medical devices may have no choice but to pursue legal action against the manufacturer who created a device that put them at risk. In some cases, there could be a class-action lawsuit that someone can join as part of their search for compensation.
