US based device maker Abiomed has issued a recall for the labelling of its Impella RP Flex with Smart Assist System Catheter. Continuing the trend of recalled products in recent months for Abiomed.
The device used for patients with acute right heart failure after left ventricular assist device implantation, supports the right chamber of the heart (ventricle) by pumping blood into the pulmonary artery.
The reasons for the recall are due to incorrect instructions for use (IFU) which fail to highlight the necessary precautions needed for treating patients whose anticoagulation clotting time is less than the recommended value. With those most at risk being patients that have central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendation of 160-180 seconds.
Currently there have been no reported deaths caused by the improper labelling but up to 12 patients have reported injuries.
Due to the serious risk to patients the US Food and Drug Administration (FDA) has identified this as a class I recall.
Abiomed shared the following statement with the Medical Device Network, “Our first priority is our patients, including the safe and effective use of our products.
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“On June 29, Abiomed issued a medical device correction to customers about Impella RP Flex with SmartAssist, which is in a limited market release at 26 US hospitals. This correction updated the Instructions for Use to provide updated guidance on how to minimize the risk factors for thrombus ingestion.”
They went on to reaffirm that this was not a product removal and that Impella RP Flex technology remains available and can continue to be used safely in patients in accordance with the Instructions for Use.
This recall comes after several bad months for Abiomed who have seen over six products in its Impella range recalled due to incorrect instructions for use in patients with transcatheter aortic valve replacement (TAVR). With a total 26 injuries and four deaths related to the issue reported since the recall.
Abiomed also initiated a product recall in April for the Impella 5.5 with SmartAssist System after identifying a fault with the pump purge sidearm which had the risk of leaking purge fluid which could cause the system to stop pumping.
On June 29, 2023, Abiomed issued an Important Medical Device Advisory letter to all its affected customers advising them how to avoid risk. The voluntary correction of the Impella RP Flex with SmartAssist model number 1000323 has been distributed since November 1, 2022, and up to 65 devices have been recalled so far.
The heart pump for patients experiencing right heart failure was first used in patients in December 2022 with the initial three patients weaned off device following 14 days of use.
In October 2022, the FDA gave Impella RP Flex Premarket Approval to treat acute right heart failure.