Four Notable Medical Device Recalls

The quality of our state’s health care is one thing for which many Oregonians are particularly thankful. While it is true that the country is currently debating issues of accessibility, most would agree that our health care providers are well-trained and conscientious. Additionally, technology, hard work, and creativity have combined to produce medical devices that can improve, prolong, and even save our lives.

Unfortunately, there have also been instances where medical devices caused great harm or have even been recalled based upon the fear of causing future harm.

In this article, we will discuss four notable medical device failures, resulting in recalls.

What is a “Medical Device?”

For our purposes, we will define the term “medical device” to mean any instrument used in the diagnosis, treatment, or prevention of a medical condition or disease. This could include products ranging from simple tongue depressors to a complicated artificial joint or MRI machine.

The U.S. Food & Drug Administration (FDA) provides a much more complex definition, which is important when it comes to determining which legal regulations apply. The most important distinction is that the definition of medical device does not include drugs, which seek to treat or affect a person (or animal) by chemical action or metabolization.

Notable Recalls

Medical devices are routinely recalled by the thousands. In fact, in 2017, the FDA issued over 9,000 recalls. Thus, the following recalls represent only a tiny sampling:

  1. Pacemakers Recalled – In 2017, Abbott recalled nearly 500,000 pacemakers in the United States. The company indicated the existence of a cybersecurity threat that could allow third parties to access the pacemaker, even while implanted. The third party would then theoretically be able to alter the speed of the pacemaker. Luckily, there have been no reported incidents of such unauthorized access. Abbott has developed an update to the product. (As an interesting aside, in 2011 the FDA reported that software failures caused 24 percent of that year’s medical device recalls.) Other companies have had problems with pacemakers, also resulting in recalls.
  2. Catheters Recalled – In January 2016, a number of Cook Medical Catheter Sets and Trays were recalled. The FDA information provides that as the result of a manufacturing error, tips could split or separate from the catheter and enter the bloodstream. Obviously, such an event could cause great danger and harm. The FDA reported 13 serious adverse events and one death. It should be noted that catheters from a variety of manufacturers are a high-recall item.
  3. Spinal Fusion and Bone Stimulators Recalled – In February 2018, Zimmer Biomet recalled bone growth and spinal fusion stimulators. These devices are put inside a patient during surgery and are designed to help bones heal. The recall resulted due to inadequate validation controls ensuring the products were free from chemical residue and bacteria.
  4. Heart Valves Recalled – Boston Scientific recalled heart valve products in February 2017. The company discovered that the pin mechanism had an issue resulting from the manufacturing process.

What Happens When an Injury Results from a Medical Device?

The law provides patients with important rights when they are wrongfully injured by medical devices. In some cases, manufacturers can be held liable under a products liability theory. In other situations, doctors, hospitals, and other medical care providers can be held liable under a negligence theory for wrongful conduct, such as negligently implanting a device or improperly treating a patient.

Call with Questions

If you have been injured by a medical device, it can be difficult to determine exactly who is responsible and what your rights are. The experienced medical malpractice and products liability lawyers at Nelson MacNeil Rayfield will be happy to answer your questions. And if you need assistance, we can help you investigate your claim. We believe that society can only be made safe from wrongful conduct by holding wrongdoers accountable for their actions. Please call at your convenience.


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