Class II

Medical Device Recall: Bubble Sensor (REF: 70105.5720)

Maquet Medical Systems USA · December 28, 2023

Reason for Recall

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Distribution

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

States Affected

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA, WI

Quantity Affected

274 units (70 US, 204 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1053-2024

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.

Maquet Medical Systems USA Medical Device Recall: Bubble Sensor (REF: 70105.5720) | SafeCheck