PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 3, 2023 Initiated: April 4, 2023 #Z-1462-2023

Product Description

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.

Details

Recalling Firm
Datascope Corp.
Units Affected
54 units
Distribution
International distribution in the country of Brazil.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32. Recalled by Datascope Corp.. Units affected: 54 units.
Why was this product recalled?
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1462-2023.