Recall of Cook Medical’s Sizing Catheters

Sizing catheters, made in many different lengths and configurations, are used to address a range of patients’ angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. These catheters have marker bands that are used to appropriately orient the catheter within a patient’s body. The tips come in “straight,” “PIG,” and “VCF,” and the catheters can be up to 100 cm. Recently, the manufacturer Cook Medical sent a letter to impacted customers that recommended specific sizing catheters be removed from their sales point or site of usage. The affected catheters are the Centimeter Sizing Catheters, the Aurous Centimeter Sizing Catheters, and the Beacon Tip Centimeter Sizing Catheters. Cook Medical has advised that the affected sizing catheters should not be used. The FDA has since issued a recall. If you or a loved one was injured by a sizing catheter, call the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved around the nation.

Call Moll Law Group About Your Sizing Catheter Claim

On April 2, Cook Medical sent out a letter to tell affected customers that they should examine their inventory to figure out whether they had affected products and quarantine those affected products that weren’t already used. The company had found that the marker bands on specific catheters could be at an increased risk of breaking or cracking.

Customers were also told not to distribute or use whatever was remaining of the affected products. Adverse events related to the sizing catheters can be reported to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.

Also, in April the FDA published an early alert that the catheters in question were linked to an increased risk of cracking or breaking while being used. There were no injuries or deaths, but the risk of increased times for the procedure, dangers associated with fragmenting the device, and vessel injury, was thought to be notable.

Since then, the U.S. Food and Drug Administration has also finalized its Class I recall for specific lots of the affected catheters. A Class I recall is the most serious kind of recall; it is issued when there’s a reasonable probability that using the product in question will generate severe negative heath outcomes or even death.

If you were already injured or a loved one was injured or killed by a fragmenting catheter or otherwise defective catheter, you may be able to seek relief in a product liability lawsuit. These lawsuits can be brought in connection with three different actionable types of defects: marketing, manufacturing or design. Since the issue here appears to be cracked marker bands, the defect is likely one of manufacturing or design. Theories of liability we may need to establish in order to recover damages on your behalf vary according to state law but may include negligence, strict liability, breach of warranty, breach of contract, and statutory violations.

Consult an Experienced Product Liability Attorney

If you or a loved one was injured by the recalled sizing catheters, call the knowledgeable Chicago-based product liability lawyers of Moll Law Group to determine whether you have a viable basis to sue for damages. Complete our online form or call us at 312.462.1700.