This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Medline ReNewal has issued a letter to affected customers recommending certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters be removed from where they are used or sold:

Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheter, Supreme Electrophysiology 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.

On July 14, Medline ReNewal sent all affected customers a letter recommending the following actions:
- Immediately check your stock for the affected item number(s) and the affected lot number(s). Quarantine all affected product immediately.
- 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.
- 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.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Medline ReNewal stated that specific lots of reprocessed electrophysiology 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 July 29, Medline ReNewal 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 ReNewal at recalls@medline.com or 866-359-1704.

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.