What Went Wrong: Analyzing a Medical Device Recall


For medical manufacturers, a medical device recall is their worst nightmare. Your company will be scrambling to halt production, provide rapid customer service to a large amount of customers at the same time, respond to revenue loses and mitigate damage to your brand’s reputation, all while working with the FDA. The only thing worse than a regular recall is a Class I recall, which is for products that have been shown to cause serious injury or death. In this blog, we will be reviewing a Class I medical device recall described by the FDA to see what may have gone wrong and ensure that your company never makes those mistakes.

Class I Medical Device Recall Case Study:

Mighty Bliss Electric Heating Pads

What Happened?

According to the information provided by the FDA, Whele LLC recalled specific Mighty Bliss electric heating pads after receiving customer complaints about the products burning customers’ skin, overheating, sparking, burning, or presenting other electrical problems. The recall involved over half a million products in the U.S., which had been distributed for approximately one year. Based on Whele LLC reports, there were 286 customer complaints related to this recall between July 2021 and September 2022. While there have been no reports of death, there have been 31 reported injuries such as electric shocks, burns, and skin burns, rashes or irritation.  Whele LLC described that the resulting severe burns “may result in infection or formation of scar tissue” (Gizmodo).

Possible Factors for Recall

Insufficient Product Testing and Oversight by Quality Assurance

Product testing is an inherent part of the medical device process. Analyzing potential hazards and product testing begins in research and development and it is the main objective of the quality assurance department. For a product to have a Class I recall because it caused harmful injuries to customers, something must have gone wrong during product testing. Here are some common difficulties that negatively impact product testing:

  • Mismanaging time and rushing to deliver new products by deadlines. Every company wants to outpace their competitors in releasing their latest products, but you have to sufficiently invest time in product testing. Companies that find themselves scrambling to deliver their products on time are usually setting unrealistic timelines from the start or working inefficiently for the bulk of their development process. With the right tools, it is possible to streamline development so your team stays calm, is able to test sufficiently and you are prepared for upcoming deadlines. Learn how to simplify your development and approval process.
  • Lack of collaboration between R&D and QA. For medical manufacturers, it is common for R&D and QA to disagree about how much testing is sufficient for a new product. Disagreements aren’t necessarily bad, but both departments need to work together to come up with a reasonable testing plan that adheres to compliance standards and protects customers. Infighting and trying to “win” arguments will just slow you down rather than making your products safer. Sometimes, an outside advisor is needed to reunite teams that spend more time fighting than working together. With 25 years of experience, the consultants at Datix can help you resolve interdepartmental issues by aligning your business processes. Read how Datix can streamline your systems.
  • Insufficient testing resources. Testing is a lot of work. Planning out how to test a product, managing the tests, and having the money to complete extensive testing is an investment that companies can be tempted to skip when resources are tight. Unfortunately, a recall will cost your company far more than sufficient testing in the long run because it can hurt your customers, damage your brand’s reputation, remove profits, and logistically overwhelm your teams.
Lack of Assessment from Customer Service

In this recall, 286 customers filed complaints, suggesting that the customer service team may have been able to identify this problem and initiate CAPA sooner if they were using a better customer support management tool. Medical manufacturers need to have CAPA in place, but it will only be triggered if you have effective a customer service system. With a well set up ERP system, it is possible for medical manufacturers to use automated notifications that trigger predetermined business processes for a variety of circumstances. For instance, if a product has over fifty complaints within the first month of being released, certain staff/departments are notified and there is automatically a review meeting scheduled. Another critical factor is having complaints marked by severity level and automated notifications for high priority complaints. Certainly, a complaint related to serious injury like burning a customer requires faster attention and more thorough review than a complaint about a product being made from a scratchy material. When you have clear business processes for possible outcomes, it becomes simple to make your software automatically initiate your systems if it is configured correctly. If you are worried that you aren’t utilizing these key customer service features, talk to a trusted software consultant like Datix. With 25 years’ experience supporting manufacturers and experts in all of the major software platforms, our team will study your business processes closely to understand your strengths, find areas for improvement, and align your goals with your software. Hear what Datix can do for you.

Wrap Up

No one wants to face a recall, let alone a Class I recall. And you don’t have to. Medical manufacturers don’t have to worry about facing a recall when their systems are running optimally. With Datix by your side, you can rest easy knowing that your business processes and software are tailored to removing the threat of a recall.

Read how you can improve your software

About Datix

For medical manufacturers, Datix is the software consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.

Learn More About Our Mission to Our Clients 

Tech Stressed?

Top Posts

Subscribe For More Content