News | Cath Lab | December 18, 2019

Cook Medical Recalls CrossCath Support Catheters Due to Marker Bands Dislodging

Vendor said defect due to a manufacturing error which may cause the marker bands to dislodge or cause buckling

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).

Additional Resources:

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

Related Content

Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Overlay Init