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 has issued a letter to affected customers recommending certain Medline kits containing Medtronic DLP Left Heart Vent Catheters be removed from where they are used or sold:

Description	Kit Lot Number	Kit Lot Number	UDI-DI (Case)
Valve Pack-LF	24DMG366	10195327177966	40195327177967
Valve Pack-LF	25EMD672	10195327678227	40195327678228
Valve Pack-LF	25GMD016	10195327678227	40195327678228
Valve Pack-LF	25AMB610	10195327678227	40195327678228
Valve Pack-LF	25BMJ241	10195327678227	40195327678228
Valve Pack-LF	25CMI425	10195327678227	40195327678228
Valve Pack-LF	24DMC189	10195327678227	40195327678228
Valve Pack-LF	24EMC463	10195327678227	40195327678228
Valve Pack-LF	24GMJ353	10195327678227	40195327678228
Valve Pack-LF	24IMB824	10195327678227	40195327678228
Valve Pack-LF	24KME116	10195327678227	40195327678228

What to Do

Do not use affected product. Review your stock for affected items and lots and quarantine affected product. After completing the recall actions, destroy affected product.

On August 21, Medline sent all affected customers a letter recommending the following actions:

Immediately check your stock for the affected item numbers and the affected lot numbers listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.
Please use the link and the information below to complete your response form.
Please list the quantity of affected product you have in inventory on the form.
Even if you do not have any affected product in inventory, please complete and submit the response form.
Website link: https://recalls.medline.com
Recall Reference #: R-25-181-FGX1
Your account will receive credit once the response form is submitted.
If you are a distributor, or if you 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 that customers destroy any affected product. You should include your customers’ quantities on your response form.

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 is issuing a recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters. Medtronic is issuing a recall of their DLP Left Heart Vent Catheters due to issues identified with certain lots of cannula products where the catheter may not retain its shape. As of July 28, 2025, Medtronic has received 41 complaints reporting that the catheters are resisting shape retention when being bent, with three reported injuries for perforation, and the remaining complaints reported for prolonged procedure or procedure delay with no patient consequence.

The potential harm when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harms are abrasion and perforation (major or critical). Medtronic has not received any complaints resulting in patient death; however, perforation of critical heart tissue – if complicated, unnoticed, or untreated – may lead to the potential risk of death.

As of July 28, Medtronic has reported three serious injuries and no deaths associated with this issue.

Device Use

Medline Convenience Kits include two or more different medical devices packaged because they are frequently used together in a health care setting.

The Medtronic DLP Left Heart Vent Catheters within the convenience kits are intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

Contact Information

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

Additional FDA Resources

Unique Device Identifier (UDI)

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