December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S. Food and Drug Administration (FDA) has identified this week as a Class I recall. The FDA said the devices may cause serious injuries or death.
Cook identified an error during manufacturing that may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014” wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018” wire guides). Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.
Use of the affected product can cause increased procedural time to obtain a replacement, increased procedural time due to difficult advancement of the catheter through a lesion, additional intervention to remove a catheter that becomes stuck within a lesion, additional intervention to remove separated marker band(s). There is also the potential that the separated marker band cannot be retrieved, and it can cause permanent impairment like loss of limb; or the fragment can embolism, obstructing blood flow, resulting in life-threatening harm, including stroke or death.
The CrossCath Support Catheters are designed to support a wire guide during percutaneous access of blood vessels in the cath lab. The device allows for exchange of wire guides, and provide a pathway for the delivery of saline solutions or diagnostic contrast agents. The catheters have three radiopaque markers spaced equally along the catheter to aid in estimating lengths within the blood vessels so the catheter can be visualized under X-ray angiography use to guide cath lab procedures.
The effected lot numbers are 9945302, 9945303, 9953512, 9945301, 9950878 and 9953506. Model numbers: CXC3.0-1.9-14-90-P-NS-0, CXC3.4-2.2-18-90-P-NS-0, CXC3.4-2.2-18-135-P-NS-0 and CXC3.4-2.2-18-150-P-NS-0. These were manufacturing between Aug, 13, 2019 to Aug. 16, 2019, and distributed between Sept. 3, 2019 to Sept. 19, 2019
The recall affects interventional cardiologists, interventional radiologists and surgeons who use the CrossCath Support Catheter.
On Nov. 8, 2019, Cook Medical issued an urgent medical device recall to customers, advising them of the product issue and provided the following instructions:
• Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused.
• Immediately cease all distribution and use of this product.
• Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit.
• Refer to the Acknowledgement and Receipt Form for return instructions.
Cook said the unaffected products that are returned will not be credited.
Even if a center does not have have any affected devices on hand, they must still complete the Acknowledgement and Receipt Form.
Adverse events should immediately be reported to Cook Medical Customer Relations by phone at 800-457-4500 or 812-339-2235, Monday through Friday between 7:30 a.m. and 5 p.m. (Eastern), or by e-mail to: [email protected].
Customers with questions or concerns can contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time).
Class 1 Device Recall Cook Medical CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0
Class 1 Device Recall Cook Medical CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0
Class 1 Device Recall Cook Medical CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0
Class 1 Device Recall Cook Medical CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0