The recall involves updating instructions for use and does not require the devices to be removed from where they are used or sold, according to a Feb. 14 FDA news release.
The Class I recall warned that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment or removal. This interaction could result in optical sensor damage and temporary or permanent pump stop, potentially causing a loss of certain heart and blood pressure readings.
The Impella RP Flex with SmartAssist System Catheter is used for up to 14 days in patients with acute right failure after left ventricular assist device implantation. There have been no reported injuries or deaths.
