The Anatomy of a Medical Device Recall

A medical device recall can be initiated when a manufacturer realizes the product violates safety laws or is a health risk. The manufacturer may try to fix the problem or remove the unit. In the former response, the manufacturer will attempt to remedy the problem associated with the medical device and simultaneously allow it to stay on the market. 

A removal action actually takes the product away from retailers and distributors with the intention of fixing the problem. If the device is removed, it will be returned to the manufacturer for processing. However, if the device is implanted in the body, the doctor will need to decide if removal is appropriate for each patient depending on the issue at hand.

Common Reasons for a Recall

The following are common reasons a product is recalled:

  • Repair
  • Inspection
  • Device relabeling
  • Settings adjustments
  • Patient monitoring
  • Patient notification

Does the Manufacturer Issue the Recall?

In the majority of cases, the manufacturer voluntarily recalls the medical device or alerts the FDA to the problem. If the FDA discerns that the product is dangerous to patient health or if the manufacturer refuses to voluntarily recall the itam, the FDA can initiate a medical device recall.

What Happens When the FDA Is Alerted to a Recall?

When the FDA learns there is a problem with a medical device, it will examine the company’s proposal to handle it. They look for the degree of physical harm the medical device causes and whether it violates FDA rules of safety. The FDA can also assign a classification to the recall. 

There are three classifications. The first is Class I. This classification means that the product has the potential to cause serious injury or death. Class II designates a device that may have temporary health problems associated with it or has the potential for serious injury or death. Class III is the least worrisome and designates a product that has no reasonable expectation of injury to the patient. 

The Public Needs to Know About Medical Device Recalls

In order for patients to be aware of recalls, the FDA has established the Medical Device Recall Database. When the device is recalled, the FDA enters it into the database. Likewise, when the recall is over, the database is updated with this information. In addition, once the recall goes through the classification process, it is entered into the FDA Enforcement Report. 

Compensation for a Defective Medical Device

If a medical device is defective, it can cause serious injury or death to patients. While this may be a mistake or a lack of care on the manufacturer’s part, the end result is that a patient pays for it both physically and financially. That is where the Olinde Law Firm can help. We are able to investigate the product and provide evidence for a product liability lawsuit, which helps the patient or a family who lost their loved one with a wrongful death lawsuit.

Call the Olinde Law Firm if you are having issues with a medical device or are aware of problems with it. You can reach us at (800) 587-1889 or message us online. Although it is devastating to learn that you are suffering because of a defective medical device, taking the first step toward recovering damages is essential. Obtain compensation for all medical expenses, lost time from work, pain and suffering and loss of consortium. Don’t go it alone, let us help you through this difficult time.