Medline Industries Recalls Electrophysiology and Ultrasound Catheters

Detected March 12th, 2026

Summary

Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.

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What changed

Medline Industries, in coordination with the FDA, has issued an expanded recall for specific lots of reprocessed electrophysiology and ultrasound catheters. The FDA has classified this as a Class I recall, the most serious type, due to the potential for residual particulates on patient-contacting surfaces. These particulates could lead to inflammatory responses, systemic infections, granulomatous reactions, or thrombus formation, potentially causing embolism or deep vein thrombosis. The affected products include various St. Jude Medical, Abbott, Webster, and AcuNav catheter models.

Healthcare providers and distributors in possession of the affected product lots must quarantine them immediately and return them to Medline Industries. Distributors are also required to notify any downstream customers or individuals to whom the product may have been resold or transferred. While Medline has reported no serious injuries or deaths to date, the potential for serious harm necessitates immediate action to remove these devices from use. Customers should consult Medline's recall communications for specific return instructions and response form completion.

What to do next

Check inventory for affected Medline reprocessed electrophysiology and ultrasound catheter lots.
Quarantine any affected product immediately.
Notify downstream customers if product has been resold or transferred.
Return affected product to Medline Industries as per their instructions.

Source document (simplified)

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.*

Medline Industries has issued an expansion to this recall.

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

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

Catheter Recall Expansion: 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.

Timeline of Communication Updates

| Date | Actions |
| --- | --- |
| 03/05/2026 | The FDA updated this communication include information on additional affected product and inform the public that this issue has been classified as a Class I Recall. |
| 08/06/2025 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |