Datascope Corp. Recalls CS100 IABP Devices Due to Battery Specification Updates

What Happened

Datascope Corp. has initiated a voluntary Class II recall for its CS100 IABP devices. The firm identified that the battery runtime and cycle specifications currently contained in the device’s Instructions for Use (IFU) are inaccurate and require updating to ensure proper operation and maintenance.

Which Products Are Affected

The recall affects the CS100 IABP running Software Version CS100 IABP Q.01. The scope includes all model numbers, all Unique Device Identifiers (UDI), and all serial numbers associated with this software version. Approximately 10,897 units are impacted by this recall. The devices were distributed worldwide, including throughout the United States and over 100 other countries.

What You Should Do

Datascope Corp. began notifying customers of the issue via letter on January 23, 2026. Healthcare providers and facilities using these devices should review the updated battery runtime and cycle specifications provided by the manufacturer. Users should ensure that their maintenance protocols align with the revised Instructions for Use to prevent potential power-related issues during clinical use.

Why This Matters

Accurate battery specifications are vital for life-supporting medical equipment. Ensuring that healthcare providers have the correct information regarding battery life and replacement cycles prevents unexpected device failure during critical procedures.

Source

This information is based on official recall data provided by the FDA.