The Food and Drug Administration (FDA) can recall a medical device if it presents a significant hazard to consumers’ health and safety. It issues a Class 2 medical device recall for products with a slight chance of causing serious injury, or if it produces adverse health consequences that are either temporary or medically reversible.
The FDA classifies recalls numerically based on the degree of the potential health hazard:
- Class I: Issued when the FDA believes that the product will cause significant harmful health outcomes or loss of life.
- Class II: Issued when consumers may experience severe health consequences of a temporary or medically reversible nature.
- Class III: Issued for products unlikely to cause adverse health outcomes, either temporary or permanent.
The FDA has a searchable database for recalled medical devices on its website. The agency has issued 500 Class 2 medical device recalls since 2006.
Criteria for Issuing a Class 2 Medical Device Recall
A company or manufacturer may issue a voluntary recall when it learns that one of its products might cause adverse health effects. However, the FDA can use its authority to issue a mandatory recall.
The FDA may issue a recall based upon certain factors that include:
- The medical device has caused injury or illness.
- It has worsened existing medical conditions.
- The likelihood of an injury or illness occurring to those who use the device.
- The severity of the injury or illness that could result from using the device.
- The impact on specific populations at greater risk from the device.
- The likelihood of the device creating temporary, reversible health consequences or permanent, medically irreversible health consequences or death.
Class 2 medical device recalls may apply to a specific product or several devices. They could include products from a single manufacturer or a device made by several companies working together.
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How You Learn of a Class 2 Medical Device Recall
The FDA generally notifies the public of a Class 2 medical device recall when a product is in wide distribution or poses a serious health hazard. In some cases, consumers can visit the agency’s website for recall information. In other situations, your physician or health care provider may inform you about a medical device recall.
Unfortunately, manufacturers and the FDA are not always forthcoming about dangerous or defective medical devices. That is why a personal injury lawyer might suggest you ask your doctor these questions before you have a device implanted or use one for your medical condition:
- Do you know if this device has been recalled?
- Do you know if many patients have reported adverse side effects?
- What is the efficacy and safety information about this device?
You may want to ask your health care provider if you can speak confidentially with other patients who use the same device.
What to Do if Your Medical Device Is Recalled
A medical device recall does not always mean that you must immediately stop using the device or have it removed (for example, if you have a pacemaker surgically implanted). Sometimes, a Class 2 medical device recall serves as a warning to consumers that their device needs to be adjusted or checked.
Depending on the potential health dangers posed by the medical device, the FDA might choose which type of recall is the best solution:
- Corrective recalls: These attempt to correct or reduce the adverse health consequences by fixing, adjusting, or taking other corrective measures.
- Removal recalls: Announced when the FDA believes that corrective actions are not enough to protect consumers’ health or are impractical for a specific type of medical device.
When an implanted Class 2 medical device could fail or create adverse health consequences, the FDA could recommend that patients talk to their doctor about the risk of removing the device compared to leaving it in place but monitoring for signs of health issues.
Recent Class 2 Medical Device Recalls
Here is a partial list of recent recalls for Class 2 medical devices:
- Stryker Rejuvenate hip devices
- Zenith abdominal endovascular graft
- WallFlex Biliary fully covered stent system
- Tibial (ankle) insert
As the Legal Information Institute (LII) explains, manufacturers have a responsibility to ensure that they make safe products that perform as stated by the company. When manufacturers fail to uphold this duty of care, and either recklessly or knowingly endanger consumers with known adverse health outcomes, patients can hold them liable.
When to Call a Lawyer About a Class 2 Medical Device Recall
If you or a loved one suffered injury or illness from a recalled Class 2 medical device and have financial and emotional damages, you might want to consult a lawyer.
A personal injury lawyer who accepts Class 2 medical device recall cases can protect your rights and help you seek compensation and justice.
Medical manufacturers and marketing companies often count on using their wealth and power to intimidate people who suffer harm from defective devices. Sometimes, their insurance companies or lawyers offer to settle only for an amount that will not cover your economic and emotional damages.
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Ben Crump Law, PLLC, is a personal injury firm dedicated to being the legal advocate for people suffering through no fault of their own. It would make us happy to help you and your loved ones recover awards for damages such as medical care, lost pay, and pain and suffering.
To learn more about how we might help you recover damages from a product subject to a Class 2 medical device recall, call our team today at (800) 959-1444 for your free case review.