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Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter because the catheters’ Instructions for Use (IFU) do not appropriately address precautions for health care providers to take when treating patients whose anticoagulation clotting time is below the recommended value. Patients with central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendation of 160-180 seconds are most at risk.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Please be aware, this recall is a voluntary correction, not a product removal.

Questions?

If you have questions about this recall, contact Abiomed’s Clinical Support Center at 1-800-422-8666.