Medline Industries Recalls Catheters Due to Particulates and Infection Risk

Detected March 6th, 2026

Summary

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.

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What changed

The FDA has identified a Medline Industries recall of reprocessed electrophysiology and ultrasound catheters as the most serious type, posing risks of inflammatory response, systemic infection, or embolism due to potential particulates. This recall is an expansion of a previous action, and affected product lots must be destroyed after recall actions are complete.

Healthcare providers and medical device makers must immediately check inventory for affected items, quarantine them, and destroy them upon completion of recall response actions. Distributors are required to notify downstream customers of this recall. While Medline has not reported serious injuries or deaths associated with this issue, continued use of affected devices could lead to serious injury or death.

What to do next

Check inventory for affected Medline ReNewal catheters.
Quarantine all affected product immediately.
Destroy affected product after recall response actions are complete.
Notify downstream customers if product has been resold or transferred.

Source document (simplified)

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.*

This is an expansion of a previous recall.

Product lots identified in this communication should be destroyed after recall actions are complete.
Product lots identified in the prior communication Catheter Recall: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters should be returned to Medline Industries

Affected Product

The FDA is aware that Medline Industries has issued a letter to affected customers recommending certain reprocessed electrophysiology and ultrasound catheters be removed from where they are used or sold.

Affected Medline ReNewal devices:

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
Biosense Webster CS Electrophysiology Catheter
Biosense Webster SoundStar Ultrasound Catheter
ACUSON AcuNav 8F Ultrasound Catheter
ACUSON AcuNav 10F Ultrasound Catheter Full List of Affected Products

What to Do

Check your inventory for affected items and quarantine immediately. Destroy affected product after recall response actions are complete.

On December 22, Medline Industries sent affected customers a letter recommending the following actions:

Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.
Please complete and return the enclosed 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.
Your account will receive credit once the response form is submitted, if applicable.
If you are a distributor or have resold or transferred this product to another company or individual, you are required to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers’ quantities on your response form.

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 not reported any 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 issue should contact Medline Industries at recalls@medline.com or call 866-359-1704.

Additional FDA Resources

Catheter Recall: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters [03/05/2026]
FDA Enforcement Report
CDRH Recall Database

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.