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

Source: FDA · Worldwide

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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 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 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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Datascope Corp. is recalling over 10,000 CS100 IABP units to update battery runtime and cycle specifications in the product'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.