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Medium severity

CS300 IABP. Software Version CS300 IABP C.01.

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateJanuary 23, 2026
ReportedMarch 11, 2026
Recalling firmDatascope Corp.
Country / regionUnited States NJ

Hazard

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Affected products

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