Datascope Corp. Recalls CS100 IABP Devices Due to Battery Specification Updates
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Datascope Corp. is recalling over 10,000 CS100 IABP units to update battery runtime and cycle specifications in the product's Instructions for Use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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.
Original source: FDA Official Notice ↗
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