Medical Device Recall: Impella RP Flex with SmartAssist; Product Number: 1000323;
Abiomed, Inc. · December 12, 2024
Reason for Recall
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Distribution
Domestic: Nationwide Distribution International: Canada
States Affected
NATIONWIDE
Quantity Affected
2,364 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0830-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.