Medtronic has issued a recall for several aortic root cannula devices due to a potential safety risk that could cause loose material to dislodge during use, potentially leading to stroke or death.
The recall, identified as the FDA’s most serious, affects the DLP Aortic Root Cannula, MiAR Cannula and DLP Aortic Root Cannula with Vent Line used in heart bypass surgeries, according to a March 31 FDA news release.
The company issued an urgent recall notice on Feb. 5, advising healthcare providers and facilities to stop using and to return any affected devices immediately.
No injuries or deaths have been reported.
