The FDA is advising all users and medical professionals of important updates involving the December 12, 2024 recall of Abiomed, Inc.’s Impella RP with SmartAssist and Impella RP Flex with SmartAssist.
Indicated for patients who develop acute right heart failure following implantation of a left ventricular assist device, the Impella RP Flex with SmartAssist System Catheter is used for as many as 14 days. It is positioned through the internal jugular vein and conveys blood into the pulmonary artery to support the heart’s right chamber.
While the December recall is not one that involves a removal of the product from the market, all Abiomed Inc. customers were sent an Urgent Medical Device Correction alert which made the following notes:
- the product does not need to be removed from its place of use and does not need to be returned.
- the correction notice should be forwarded to all personnel who handles the device at the facility.
- in the event that the devices have been forward to a different facility, the safety notice should also be forwarded to that facility.
- all users should carefully refer to the updated instructions in the Urgent Medical Device Correction notification “when inserting, manipulating, or removing concomitant devices.”
On February 14, 2025, consumers were alerted to updated use instructions for Abiomed Inc.’s Impella RP with SmartAssist and Impella RP Flex with SmartAssist. The change was made to account for “a risk that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment, or removal.” When this happens, damage to the optical sensor and temporary or permanent pump stop may occur, and, in such an event, alarms may be triggered and certain heart and blood pressure readings may become lost.
Affected Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices are marked by Unique Device Identifier (UDI)/Model 00813502011869 and 00813502012811.
U.S.-based customers are encouraged to reach out to Abiomed with any questions via email at onemd-field-actions@its.jnj.com.
As the FDA continues to monitor this recall, any adverse reactions or quality issues observed by users or healthcare providers should be reported to the agency’s MedWatch program.
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