Datascope Corp. Recalls CS300 IABP Devices to Update Battery Specifications

Source: FDA · Worldwide

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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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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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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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Datascope Corp. is recalling over 10,000 CS300 IABP units to update battery runtime and cycle specifications in the device's Instructions for Use.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.