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Early Alert: Cardiac Cannula Issue from Medtronic
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. Medtronic has 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 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.
Questions?
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.
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