FDA announces new recall of Johnson & Johnson heart pumps over safety concerns
The U.S. Food and Drug Administration (FDA) has announced that Abiomed, now known as Johnson & Johnson MedTech, is recalling its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps over ongoing safety concerns. No heart pumps are being removed from the market for this recall; instead, the instructions have been updated to help clinicians avoid any issues.
This is a Class I recall, according to the FDA. The agency said that using the devices without reviewing the updated instructions could “cause serious injury or death.”
Safety risks prompt recall
The recall was put in place due to an increased risk that the tip of guide wires or other medical devices could come into contact with the heart pumps during “insertion, adjustment or removal.”
“The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop,” according to an advisory now live on the FDA’s website. “This may trigger alarms and cause a loss of certain heart and blood pressure readings.”
Johnson & Johnson shares statement
“We have not identified any manufacturing or design issues, and no patient injuries have been reported related to the optical sensor damage,” a Johnson & Johnson spokesperson told Cardiovascular Business.
The spokesperson also emphasized that this recall is designed to educate customers.
“Please note that this recall is not a product removal and Impella heart pumps remain available for patients,” they said. “Educating healthcare professionals about recommended practices to improve outcomes for patients remains a priority, and we remain dedicated to the mission of providing safe and effective life-supporting heart pump technology to patients worldwide.”
Customers warned to follow updated instructions
Johnson & Johnson MedTech issued an urgent medical device correction about these concerns on Dec. 12. The document recommends that customers lower the pump flow level to P-2 and use medical imaging guidance when “inserting, manipulating or removing any guide wires, indwelling venous lines or devices.” If optical sensor damage does occur, customers will notice a “Placement Signal Not Reliable” alarm that goes off; no other actions are required.
The company also emphasized that, in the event of a pump-stop brought on by this issue, clinicians should follow all instructions listed when the “Impella Stopped” alarm appears.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.