Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk

Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the start of a case, potentially leading to persistent alarms and serious injury or death.

The U.S. Food and Drug Administration has classified this recall as the most serious type, indicating a high level of risk to patients. The agency warns that continued use of the affected devices could result in severe outcomes.

Customers were instructed on May 18 to review their inventory, quarantine any sets with the listed serial numbers (613525, 644314, 645428, 644591, 672986, 673252, 677223), and return the products to Sedgwick. The recall notice also advises facilities to share the information with staff who handle, store, or use the devices and to post the notice visibly.

Abiomed’s letter emphasizes that the recall does not change other product recommendations, but stresses immediate removal of the affected sets to prevent any adverse events.