Medical Device Industry Experiences Record High Class I Recalls

Medical Device Industry Experiences Record High Class I Recalls

A defective medical device can cost people more than just money. In 2022, there was a surge in Class I recalls among several major medical device companies. Medical devices subject to Class I recalls present the highest level of risk, putting patients’ health and lives at stake. Given the severity of the situation, let’s take a closer look at the numbers and data behind the 2022 Class I recalls to understand the impact on patients and the industry as a whole.

Class I Medical Device Recalls Hit a 15-Year High 

Sedgwick, a leading global provider of technology-enabled risk assessments, recently analyzed the FDA data on Class I recalls for 2022. Several prominent medical device companies were subject to the FDA’s Class I recall labeling in 2022. These companies include Abbott, Baxter, GE HealthCare, Medtronic, and Philips. 

The total number of recalls increased by 8.1% during the last three months of 2022. Additionally, the number of recalled units increased by approximately 10 million to 61.98 million.

During the fourth quarter, mislabeling remained the leading cause of recalls, a trend observed in three out of the past five quarters. Quality issues were the second most common cause. Interestingly, software-related recalls decreased from 46 in the prior quarter to 15 in the last three months of 2022. 

Different FDA Recall Classifications

Class I recalls are the most serious type of product recall issued by the FDA. The agency uses a Class I designation for situations where the use of or exposure to the product will cause serious adverse health consequences or death. Whereas Class II recalls are for products that may cause temporary or reversible injuries or when there is only a slight chance of health consequences. Class III FDA recalls are the least dire type of product recall, typically involving products unlikely to cause adverse health consequences. 

Mislabeling and quality problems were the most common reasons for the Class I recalls in 2022.

Examples of Class I Recalls in 2022 

Philips, whose recall of its CPAP, BiPAP, and ventilator machines landed the company in hot water in 2021, initiated multiple recalls in 2022. In September 2022, Philips recalled masks used with its CPAP and BiPAP devices over concerns about the magnets inside. The FDA labeled this a Class I recall because of the risk of injury or death if the magnets interfere with implanted metallic medical devices in the body. Philips also recalled its long-awaited and supposedly fixed ventilators in 2022. The new foam in the repaired ventilators could block the airways because Philips failed to use adhesive to secure it. Also, the machines still had leftover toxic particles from the previous sound abatement foam. 

Meanwhile, Medtronic faced three separate Class I recalls for its HeartWare Ventricular Assist Device (HVAD) system. The HVAD system provides additional blood flow to heart failure patients, but several injuries and deaths have been linked to the pump. Welding and battery defects resulted in the three HVAD system Class I recalls in 2022. 

Class I Recalls Into 2023 

Sedgwick anticipates the increase in recalls to continue into 2023, with January alone seeing 135 recalls. This quantity is much higher than the monthly average of 80 recalls in the fourth quarter. 

However, Sedgwick presented a silver lining: the FDA’s Section 518 authority. Sedgwick considers this one of the most significant developments in medical device recalls, as it allows the FDA to order manufacturers to notify patients and providers of risks. The agency previously used this power to demand Philips inform patients about the June 2021 recall. 

Ideally, the FDA will continue enforcing its Section 518 authority to ensure companies practice transparency and take appropriate actions to protect the public throughout Class I recalls.  

The Lake Law Firm Can Help You

The rise in Class I recalls in the medical device industry is worrying. This stark increase in Class I recalls highlights the need for companies to prioritize quality and ensure their products are safe for patients. If you or a loved one have been affected by a medical device recall, you may be eligible to seek legal representation for your injuries. Companies that fail to issue a timely Class I recall can face legal action. Philips CPAP devices and Medtronic’s HVAD systems are just a few examples of Class I recalls that have severely injured patients. 

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529.