FDA Early Alert

Cook Medical Sizing Catheters Removed Due to Risk of Device Breakage

The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a potentially serious device issue involving certain sizing catheters manufactured by Cook Medical.

Cook Medical has notified customers to immediately remove affected products from use and distribution due to a risk of device component failure that could result in patient harm.

Affected Devices

The recall involves Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters, and Beacon Tip Centimeter Sizing Catheters. Download a full list of affected product lots by clicking on the download link in the right column of this page.

Device Use

Sizing catheters are used in angiographic procedures by trained physicians to navigate vascular anatomy, accurately position devices, and measure anatomical structures.

They are available in lengths of 70 cm and 100 cm, and tip configurations including straight, PIG, and VCF.

Reason for the Alert

Cook Medical identified that marker bands on the affected catheters may be prone to cracking or breakage.

These marker bands are critical for device positioning and anatomical orientation during angiographic procedures

Potential Risks to Patients

If a device failure occurs, potential adverse events may include increased procedural time, device fragmentation or separation, vessel injury, and the need for additional intervention.

In severe cases, device fragmentation could lead to life-threatening complications or death.

As of April 2, no serious injuries or deaths have been reported.

Required Actions for Healthcare Providers

Cook Medical has instructed customers to take the following steps immediately.

Identify and Quarantine

Review inventory for affected products and remove then isolate any impacted devices.

Cease Use and Distribution

Do not use affected catheters and stop any further distribution.

Return Affected Products

Return affected products to Cook Medical.

Notify Internal and External Stakeholders

Inform all relevant personnel and any facilities that received the devices.

Report Adverse Events

Adverse events or quality issues should be reported to Cook Medical by phone at 800.457.4500 / 812.339.2235, or by email at CustomerRelationsNA@CookMedical.com.

Healthcare providers may also report events through the FDA’s MedWatch program.

Regulatory Status

The FDA is currently evaluating this issue and has classified it as an early alert, indicating a potentially high-risk device concern. Further updates will be provided as additional information becomes available.

MDP Insight

This event highlights several critical quality system considerations. Supplier and component control failures can directly impact device integrity. Design robustness and material durability must be validated under real-world conditions. Postmarket surveillance systems must detect early signals of failure, and CAPA systems must rapidly assess and mitigate risk.

Marker band failure represents an intersection between design, manufacturing, and risk management.

Key Takeaway

Even seemingly minor components like marker bands can create significant clinical risk if they fail. This reinforces the importance of comprehensive design validation, robust supplier controls, and effective postmarket monitoring.

Links

Read the FDA’s announcement here.