Impella RP Smart Assist Catheter Gets Class I Recall for Labeling

The FDA cites inadequate product labeling as the reason for marking Abiomed’s June recall of its Impella RP Flex with Smart Assist system catheter as class I, the most serious type of recall as use of the device may cause injury or death.

This device is placed in the jugular vein and supports the right chamber of the heart by pumping blood into the pulmonary artery and can be used up to 14 days in patients who develop acute right heart failure after left ventricular assist device implantation.

Clinicians may, however, continue to use the devices, the FDA said, and provided recommendations for use on its website. Abiomed initiated the voluntary recall on June 29 for the 65 recalled devices in the U.S. There have been 12 reported injuries related to the recall, but no deaths.

Read the FDA recall notice here.

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