
Medtronic has 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.
On August 6, Medtronic sent all affected customers a letter to identify and quarantine all unused affected product in inventory and share this notification with others.
For more information, visit the FDA's alert page.