FDA recall Z-1462-2023

Datascope Corp. · Class II · device

Product

MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

Reason for recall

The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

Distribution

International distribution in the country of Brazil.

Key facts

Status
Ongoing
Initiation date
2023-04-04
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2023