Datascope Corp. Recalls CS300 IABP Devices to Update Battery Specifications

What Happened

Datascope Corp. has initiated a voluntary Class II recall for the CS300 IABP (Intra-Aortic Balloon Pump). The firm identified that the battery runtime and cycle specifications currently contained in the device’s Instructions for Use (IFU) are inaccurate and require updates to ensure users have correct information regarding the device’s power capabilities.

Which Products Are Affected

The recall affects the following medical devices:

• Product Name: CS300 IABP
• Software Version: CS300 IABP C.01
• Quantity: 10,897 units
• Identification: The recall applies to all model numbers, all Unique Device Identifiers (UDI), and all serial numbers associated with this software version.
• Distribution: The units were distributed worldwide, including nationwide across the United States and over 100 other countries.

What You Should Do

Datascope Corp. initiated the recall process by sending notification letters to affected customers on January 23, 2026. Healthcare providers and facilities using the CS300 IABP should review the updated battery runtime and cycle specifications provided by the manufacturer. Users should ensure that all staff operating the devices are aware of the corrected information to maintain proper device performance and patient safety.

Why This Matters

Accurate battery specifications are essential for life-support equipment like intra-aortic balloon pumps. Ensuring that medical staff understand the correct runtime and cycle limits prevents unexpected power failures during critical patient care or transport.

Source

Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: Z-1487-2026.