Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
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 recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.