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What Are the Most Common Class I Recalled Devices?

Posted on in FDA

Medical device recalls are on the rise, with patients reporting injuries and problems from defective products more often than ever. The most serious of all FDA recalls is known as a Class I, since that indicates a situation where there is a reasonable chance that exposure to or use of a product could lead to major health consequences or death.

The FDA recently completed a research project and report to explore the upward trend of defective device recalls. While there were only 7 defective device Class I recalls in 2003, that number increased to 52 in 2012. When a firm submits a correction or recall of a product to the FDA, the company is responsible for reporting the injuries and deaths at that time. Deaths were reported by 25 percent of companies involved in Class I recalls.

The FDA identified the six most likely kinds of devices to be recalled. These included infusion pumps, automated external defibrillators, ventilators, blood glucose and other system tests, catheters, and implanted pumps.

For all Class I recalls between 2003 and 2012, these six kinds of devices made up 30% of defective products reported. Just between 2009 and 2012 alone, recalls of these products were attributed to 80 percent of a 25 percent increase in total recalls.

The recall cycle can take a long time, even when well-meaning patients or physicians report issues with defective devices as soon as possible. A company won't seriously investigate a product until a few complaints have been received, and it can take 6-9 months for cooperation between the FDA and the manufacturing company to submit an official recall.

In the meantime, these devices expose patients to the possibility of injury or death. If you have been hurt by a defective device, you need to contact an Illinois defective medical device attorney today.

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