Alert on Medtronic DLP Left Heart Vent Catheters

FDA has issued an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be removed from where they are used or sold. Reports have been received about affected products resisting shape retention when being bent, according to the alert, adding that the 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),” the alert says. Perforation of critical heart tissue may lead to death, it says. To date, Medtronic has reported three serious injuries and no deaths associated with the issue.

The catheters are intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.