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FDA DeviceClass IINotable

FDA Recall: CS300 IABP. Software Version CS300 IABP C.01.

Date: 2026-03-11
Brand: Datascope Corp.
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

10,897 units

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FDA Recall: CS300 IABP. Software Version CS300 IABP C.01. | RecallWatch