Datascope Corp. Recalls CS300 IABP Devices to Update Battery Specifications
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Datascope Corp. is recalling over 10,000 CS300 IABP units to update battery runtime and cycle specifications in the device'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 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.
Original source: FDA Official Notice ↗
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