Datascope CS300 IABP Software Update Needed for Safety

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Contact the company & request your remedy

Recalling firmDatascope Corp.1300 Macarthur Blvd, N/A · Mahwah, NJ 07430-2052

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Datascope is recalling CS300 IABP devices with software version C.01 because the battery runtime and cycle specifications in the instructions need updating. This could affect safety if the battery specifications are not current.

Why it’s dangerous

The battery runtime and cycle specifications in the device's instructions need updating. If these specifications are outdated, it could lead to improper battery management and potential safety issues.

Who’s affected

Medical devices users who own CS300 IABP devices with software version C.01 are affected. Patients using these devices with outdated battery specifications may be at slightly higher risk.

How to tell if you have this one

Check for CS300 IABP devices with software version C.01. All model numbers, UDI, and serial numbers are affected.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your device's software version by checking the device settings or documentation.

✎ GovInfoNow

Questions people ask

Do I need to update the software immediately?

The recall record does not specify a deadline for updating the software.

What happens if I don't update the software?

The recall record does not specify consequences of not updating the software.

Is there a repair kit or replacement available?

The recall record does not mention any repair kits or replacements.

Take action

Contact Datascope

We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1487-2026 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-1487-2026 from Datascope.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1487-2026 (January 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1487-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.

Lower-risk recall