Class I Recall Issued on Medtronic Inc. Guidewires Used in Heart Procedures

Most product recalls are categorized by the U.S. Food and Drug Administration (FDA) as Class I, II or III. The most serious is a Class I recall, in which there is reasonable probability that in using the product it will cause serious injury or death. A Class I recall was recently issued for certain guidewires used in heart devices.

Medtronic Inc. voluntarily recalled these guidewires, which are used to guide devices, such as stents, to open arteries. The coating on the surface (designed to make it easier to slide through blood vessels) could delaminate, causing it to become detached. As a result, it increases the risk of blocking the blood vessel. The company reported receiving several complaints, with at least one patient suffering injuries.

Although they took steps toward the end of October to notify distributors and hospitals worldwide regarding the risks (and have taken necessary measures to avoid any further shipments of this product), the FDA has taken it even further by issuing a Class I recall on the product. The agency continues to seek reports from those who have suffered injury or death as a result.

FDA Recall Classifications 

Recalls categorized as a Class II are products that could cause temporary or medically reversible injuries, or have a slight risk of causing serious harm. Those issued as a Class III are not likely to cause serious adverse health problems.

There are two other types of classifications issued by the FDA. A market withdrawal is when a violation is minor and doesn’t warrant legal action. The manufacturer either corrects the problem or removes it from the market. And the other is a medical device safety alert (which may or may not lead to a recall), issued when there is an unreasonable risk that someone could suffer significant harm.

Manufacturers may be liable for any injuries or other damages that result from use of a defective medical device. If you believe you have a product liability case, contact Gacovino, Lake & Associates at 800-550-0000 to set up an appointment with a lawyer.

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