ABIOMED IMPELLA LEFT SIDED PUMPS HAVE RISK OF MOTOR DAMAGE AFTER CONTACT WITH TAVI. FDA RECALL, JUNE 2023.
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In June 2023 FDA published a recall about impella left sided pumps and TAVI.
This was actually a voluntary correction by the company. The notice affects the currently available left ventricular assist devices, primarily Impella CP and Impella 5.5. Impella heart pumps.
There is a possibility that the Impella motor housing might make contact with the distal stent of a transcatheter aortic valve replacement (TAVR). This contact could lead to damage or destruction of the motor's impeller blades.
If the Impella system is damaged, it could result in reduced blood flow or pump failure, potentially leading to insufficient support. This could be life-threatening, especially for individuals who require high levels of support.
Additionally, there is a concern that broken blade fragments could cause systemic embolization.
The company's advice to prevent complications in this setting is as follows:
• Be mindful of the potential interaction between the Impella system and TAVR.
• Take extra care when positioning the Impella system in patients with TAVR.
• Avoid repositioning the device while it is spinning.
• Switch the device to P0 mode during repositioning or any movement that might bring the outlet windows close to the valve stent structures.
• If low flow is observed in a patient who has undergone TAVR and is on Impella heart pump support:
-- Consider impeller damage as a potential cause.
-- Replace the Impella pump as soon as possible.
Fig 1. Impella catheter can be damaged by TAVR or TAVI stent struts.
