The U.S. Food and Drug Administration (FDA) has issued a recall on two types of catheter introducers. The products are manufactured by Cook Medical under Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select).

These medical products are catheter introducers with a dilator, a valve, a coated shaft, and a marker that identifies the device on an X-ray. During medical procedures, the introducers help insert other therapeutic or diagnostic medical devices into vessels (excluding those of the brain and heart).

The FDA has categorized the recall as Class I, indicating severe. It warns that using the devices may lead to severe injuries or death. The product defect can cause the separation of the device while in use, leading to adverse events.  

Dangerous and/or defective medical devices, such as these catheter introducers prone to separation, can result in serious injuries or death.

A medical device or product can be defective in design, or a defect may occur during manufacturing. There may be mistakes in product labeling that result in injuries or deaths. Lawsuits against medical or pharmaceutical manufacturers have many challenges and legal hurdles, and such cases often garner national attention. If you or a loved one has been injured by a defective or dangerous medical device, contact one of our Sacramento defective medical device attorneys to discuss your legal rights.

The recalled catheter introducers were manufactured between February 17 and September 29, 2020, and were distributed to healthcare facilities between May 23 and November 17, 2020. The number of devices recalled within the United States totals more than 37,000.  

The FDA recall website has the catalog and lot numbers for the recalled items.

Manufacturer Cook Medical has recalled the two types of introducers because of an increased potential for separation at a specific area known as the proximal bond site. If separation of the device occurs while it is in use, it could cause life-threatening consequences.

Some of the adverse events that could result from the separation of the device include:

• Lengthened procedure time / increased time under anesthesia
• The need for another procedure to remove the separated part of the catheter
• Injury to a vessel or vessels
• Blood flow blockage to vital organs
• Bleeding

While no deaths have been reported, 14 reports of significant injuries and 57 complaints have been reported.

Those that may be affected by the defective products are:

• Physicians who are using the identified lot numbers of Cook Medical introducers 
• Patients who have undergone procedures using the affected devices

In late November, the device manufacturer, Cook Medical, sent letters informing affected customers of an Urgent Medical Device Recall. The letter said Cook Medical was removing all potentially affected devices from the market. The letter also included instructions for customers as follows:

• Return products from the affected lot numbers to Cook Medical and include a copy of the Acknowledgement and Receipt.
• Distribute the Urgent Medical Device Recall letter to the appropriate staff and the user level. Share within the organization and with any organization to which the affected devices have been transferred.
• Report any adverse events immediately to Cook Medical by calling (800) 457-4500 or emailing [email protected].

It is anticipated that lawsuits will be filed due to injuries caused by the defect(s) within the Cook Medical Catheter Introducers. Medical products liability claims are usually based on a defect or defects that occurred in the manufacturing process, in the design of the affected medical device, or due to inadequate or absent warning labeling. 

A product manufacturer is required to warn of all the risks associated with the use of its products. If you were injured due to the defect of a catheter introducer manufactured by Cook Medical, you must consult with a professional medical device products liability lawyer. If you underwent additional procedures, required a lengthy procedure, or sustained damage to a vessel or blood loss, you may be eligible to receive compensation for your damages. Lawsuits against medical and pharmaceutical corporations are challenging and complex, and the businesses have deep pockets and will vigorously defend such cases. That is why you must seek a skilled attorney with experience litigating medical products liability matters.

Watch the YouTube video. The FDA has been urging the public to read product labels for years, and below is a decades-old PSA.

If you or anyone you love has sustained an injury due to a defective medical device, you are entitled to compensation for your damages. You are encouraged to act quickly – phone our office to receive compassionate, free, and friendly legal advice. Our telephone number is (916) 921-6400. If your phone has a different area code, use our toll-free line: (800) 404-5400.

Knowing about our prior case results is informative, which can be viewed here: Verdicts and Settlements.

^{Editor’s Note: updated for accuracy and relevancy [cha 5.16.23]
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