Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

The affected products below have changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Medline ReNewal has issued letters to affected customers recommending certain reprocessed electrophysiology and ultrasound catheters be removed from where they are used or sold:

• St. Jude Medical Livewire Electrophysiology Catheter
• St. Jude Medical Response Diagnostic Electrophysiology Catheter
• St. Jude Medical Supreme Diagnostic Electrophysiology Catheter
• St. Jude Viewflex Ultrasound Catheter
• Abbott Inquiry Electrophysiology Catheter
• Webster CS Electrophysiology Catheter
• AcuNav 8F Ultrasound Catheter

Full list of affected product

What to Do

Check your inventory for affected items and quarantine immediately. If you have resold or transferred affected product to another company or individual, notify them of this recall. Return affected product to Medline Industries.

• On July 14, Medline sent affected customers an “Urgent Medical Device Recall” communication recommending the following actions. On August 13, Medline sent an updated communication to previously notified and additional customers containing additional affected product. 
• Immediately check your stock for the affected item number(s) and the affected lot number(s). Quarantine all affected product immediately.
• Complete and return the response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form.
• Upon receipt of your submitted response form, return labels and RGA information will be provided, if applicable. Your account will receive credit when the returned product is received.
• If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request your customers return any affected product to you for collection and return to Medline Industries, LP.

Reason for Recall

Medline Industries stated that specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

As of December 12, Medline Industries has reported no serious injuries or deaths associated with this issue.

Device Use

Electrophysiology diagnostic catheters are intended to be used for EP mapping, stimulation and recording of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline Industries at recalls@medline.com or 866-359-1704.

Additional FDA Resources 

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates