Abiomed recalls instructions for use for right heart pump due to risk for blood clots
Key takeaways:
- Abiomed announced a recall of its instructions for use for its right heart pump system catheter due to risk for blood clots.
- This recall is a voluntary correction, not a product removal.
Abiomed announced a recall of the labeling for its right heart pump system catheter because its instructions for use do not appropriately address precautions for patients with anticoagulation clotting time below recommended value.
Patients with central venous lines and cardiac cannulas with systemic anticoagulation below the recommended 160 to 180 seconds per the system’s (Impella RP Flex with Smart Assist) instructions for use are most at risk, according to an FDA press release.
The FDA has identified this as a Class I recall, the most serious type.
This recall is a voluntary correction, not a product removal, and affects a total of 65 devices distributed from Nov. 1, 2022 to present.
There have been 12 reported injuries and no deaths associated with use of the device, which is used for up to 14 days in patients with acute right heart failure after left ventricular assist device implantation, according to the release.
The company issued the following statement to Healio by email:
“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 U.S. 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.”