Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter

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.

Affected Product

The FDA is aware that Medtronic has issued a letter to affected customers recommending certain Left Heart Vent Catheters be removed from where they are used or sold:

What to Do

Identify and quarantine all unused affected product in your inventory and share this notification with others in your organization. 

On August 6, Medtronic sent all affected customers a letter recommending the following actions: 

• Review your inventory for listed product.
• Immediately identify and quarantine all unused, listed product in your inventory.
• Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, option 1 then option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary.
• Complete the Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession.
• Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
• Please maintain a copy of this communication in your records.
• Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months. If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available.

Reason for Recall

Medtronic stated that they have received reports of the affected product resisting shape retention when being bent. These catheters are intended to be malleable and retain a bend in the shaft.  

When identified prior to use, this issue may lead to procedure delay while another cannulae is located. If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts). Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed, or untreated.

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

Device Use

This catheter is 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 Medtronic at rs.structuralheartfieldassurance@medtronic.com or call 1-800-854-3570 and select option 4.

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.

Timeline of Communication Updates