The U.S. Food and Administration (FDA) reports on, monitors, and enforces medical device recalls for public safety. But, what does that really mean? What exactly is a medical device recall and how do recalls affect consumers? Let’s take a look.
Medical Device Recalls
A recall means that the FDA and/or a manufacturer is aware of a problem with a device that could affect patient safety and health. Recalls generally follow a series of consumer complaints about a defect, malfunction, illness, or injury.
Sometimes, however, a recall is preemptive. A manufacturer may discover a problem during manufacturing before the product reaches consumers. In these cases, a recall is announced when a medical device:
- Is defective
- Could be a risk to the health of the user
- Is both defective and poses a risk to the user
When a medical device manufacturer discovers there is a problem with one of their devices, the company must propose a correction or removal based on the nature of the adverse event and the company’s plan to correct it.
Medical Device Correction or Removal
A correction is an action that takes place where the medical device is used or sold. A removal addresses the problem caused by medical device by removing it from where it is used or sold. The term “medical device recall” refers to both the correction and removal actions medical device companies take to address a problem with one of their products.
Most consumers think of removal actions when they think of medical device recalls, but any of the following types of actions may be considered recalls by the FDA:
- Inspecting a device for problems
- Issuing instructions to repair the device
- Offering repairs for the device where it is sold
- Adjusting settings on a device
- Revising or replacing the label on a device
- Destroying the device
- Notifying patients of the potential for an adverse event
- Monitoring and collecting data on patients who use the device
Often, a company may know of the potential for a problem with a group of their products, but has no way to predict which individual devices may malfunction and pose a threat. To protect the safety of consumers, the company may recall entire lots, models, or product lines.
What is the FDA’s Role in Medical Device Recalls?
When a company notifies the FDA of a corrective or removal recall action, the FDA will:
- Review the strategy the company proposes to correct the defect
- Assess the public health hazard presented by the product
- Determine whether the defect does, in fact, violate FDA regulations
- Determine whether the defect has the potential to violate FDA regulations
- Assign the recall a classification
The FDA assigns recalls one of three classifications to all recalls in order to indicate to the public the relative degree of risk.
- Class I – Indicates a reasonable chance, or high probability, that the product will cause serious health problems or death.
- Class II – Indicates that a product may cause temporary or reversible health problems. Further, there is only a slight chance the product will cause serious health problems or death.
- Class III – Indicates a product is not likely to cause any health problems or injury but the company is taking a recall action nonetheless.
The FDA monitors medical device recalls of all three classifications to ensure the company’s strategy is effective in protecting the public from harm. The FDA will only terminate a recall after the agency is assured the product no longer violates FDA regulations and no longer presents a public health hazard.
How are Medical Device Recalls Determined?
In most cases, the party responsible for a medical device will voluntarily recall their product when it learns that the product violates FDA regulations. Parties responsible for a medical device may include:
- Companies who market the device
Learning that a product violates FDA regulations should prompt the responsible party to notify the FDA and distributors, and initiate a recall. The FDA has the power to force a company to recall a device, but this is rare. The FDA more frequently nudges a device manufacturer in the right direction by issuing a safety warning to the public. Generally, a voluntary recall follows thereafter.
It has rarely been necessary for the FDA to force a recall because a company refuses to issue one. The agency would only exercise their power to do so if a company explicitly refuses to recall a device that is associated with significant health problems or deaths.
What Medical Device Recalls Mean for Consumers
Medical device recalls do not always mean consumers must stop using the device or return it to the company. Sometimes, a recall only means that the device needs to be checked, adjusted, or repaired.
Many medical device recalls will impact the conversations patients need to have with their doctors about their course of treatment. For example, a recall for an implantable medical device does not necessarily mean that the patient must have surgery to remove the device. Rather, the patient should have a conversation with their doctor about the risks of leaving the device in place versus removing it.
Medical device recall announcements can also be the catalyst that consumers need to speak to an medical device attorney. Far more medical mistakes occur than medical malpractice lawsuits are filed each year. Many victims of medical malpractice do not realize their unfortunate medical outcome was the result of negligence.
A public safety announcement from the FDA may help consumers realize that someone may be at fault for their suffering.
How Does the FDA Communicate Recalls?
To track medical device recalls, the FDA records and publishes information about the defective device in their medical device recall database. The agency will update the database if changes are needed, or if the recall is terminated.
For consumers who don’t regularly check the FDA’s reporting database, the FDA also issues press releases or other public notices about medical device recalls. The FDA may simply post the company’s press release online or on social media, or it may draft its own notice about market withdrawals or safety concerns
Examples of Medical Device Recalls
Medical device recalls may seem like a sterile administrative processes in the abstract. Therefore, it is important to consider real life examples. Keep in mind that these recalls do not happen in a vacuum or laboratory setting. Each recall represents human suffering.
Examples of some recent medical device recalls include:
- All pelvic mesh products: After years of multidistrict litigation (MDL), the FDA finally forced a recall of all pelvic mesh devices used to treat pelvic organ prolapse because of the few companies who persisted in selling the mesh.
- Wearable defibrillators: One of the largest medical device manufacturers in the world recalled these wearable defibrillators because they had the potential to misfire or fail to fire at all in the event of a cardiac emergency.
- ChemoLock and ChemoClave Vial Spikes: Closed delivery systems for chemotherapy, these chemotherapy delivery systems can release burr particulates into blood vessels. of This causes a risk of stroke and death
- Blood-thinner test strips: Some test strips give inaccurate readings for patients who need to test their blood levels at home because they take blood thinners like warfarin.
These are just a few examples of medical device recalls. Not all recalls are due to a risk of serious illness or injury. However, all recalls should be taken seriously.
Need Help? Talk to Drug and Device Watch
If you have questions about an injury or illness related to a medical device recall, contact Drug and Device Watch. It is scary that a medical device you rely on for your health may not work properly. Find out more about your options to ensure your safety and legal rights by speaking with one of our medical device attorneys.
To schedule a free case evaluation, call 1-888-458-6825, or you can reach out to us online via our online form.