J&J’s Abiomed Comments on Another Impella Recall Over Blood Clot Risk

Abiomed’s June 29 recall of Impella RP Flex with SmartAssist system catheters for blood clot risk was identified as Class I by the U.S. Food and Drug Administration (FDA). Abiomed informed the FDA that the recall is a voluntary correction, not a product removal.
 
The device’s labeling recall was initiated because the catheters’ instructions for use (IFU) don’t appropriately address precautions for healthcare providers to take when treating patients with anticoagulation time below the recommended value. The company said patients with central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendations—160-180 seconds are most at risk.
 
Abiomed advised that clinicians may continue to use the devices, but to be wary of risk of blood clots or particle deposits forming. At this time there have been 12 reported injuries, and no reports of death as a result of the error.

A statement from Johnson & Johnson, which purchased Abiomed late last year, read: “At Abiomed, our first priority is our patients, including the safe and effective use of our products. 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. This notification is not a product removal. Impella RP Flex technology remains available and can continue to be used safely in patients in accordance with the Instructions for Use.”
 
Customers were advised to maintain systemic anticoagulation (ACTs of 160-180 seconds) when indwelling central venous lines (i.e., hemodialysis, PA catheters) are present, for the duration of Impella RP Flex with SmartAssist support as clinically feasible. Risk should be assessed for extraluminal thrombus on indwelling lines as well.
 
The FDA said Abiomed is revising IFUs for the affected devices to clarify risk factors and recommendations related to clotting or deposition.

Impella had a recall beginning April 17 of specific Impella 5.5 with SmartAssist sets due to purge fluid leakage. In July, Impella heart pumps were recalled due to potential risk of unintentional interaction of the Impella motor housing with the distal stent of a TAVR.