The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling the labeling for its Impella RP Flex with SmartAssist catheter.
This is a voluntary correction, the agency explained. It is not a call to remove the product from the market. It is still categorized as a Class I recall, however, which means the FDA has said using these devices “may cause serious injuries or death.”
The Impella RP Flex with SmartAssist heart pump gained FDA approval back in October 2022 for the treatment of acute right heart failure for up to 14 days. It is implanted via the patient’s internal jugular vein with help from an 11 French indwelling catheter.
The labeling for the device’s catheter has been recalled because its Instructions for Use (IFU) “do not appropriately address” the precautions healthcare providers should take if a patient presents with an anticoagulation clotting time below the recommended value. Abiomed sent all customers a detailed list of recommendations designed to reduce the risk of thrombus formation or deposition. The company also is revising its IFU to “clarify the risk factors and recommendations” going forward.
“Patients with central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendation of 160-180 seconds are most at risk,” according to the FDA advisory. “Please note that clinicians may continue to use the devices. The use of affected catheters may cause serious adverse health consequences including the risk of blood clots or particle deposits forming or death.”
Twelve injuries and no deaths have been reported due to this issue. The recall includes 65 devices being used at 26 U.S. hospitals.
“Our first priority is our patients, including the safe and effective use of our products,” Abiomed said in an emailed statement about the voluntary correction. The company also emphasized that this update is about revising the device’s instructions, not removing it from the market altogether.
In November 2022, Johnson & Johnson announced its plans to acquire Abiomed in a deal valued at approximately $16.6 billion. The company completed the acquisition in December 2022.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.