FDA recall Z-0076-2022

Datascope Corp. · Class II · device

Product

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Reason for recall

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Distribution

Worldwide distribution - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-09-08
Report date
2021-10-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2022