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.
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:
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:
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.
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.
This catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.
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.
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.
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.