Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump Recall: Preventative Maintenance Update

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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 Cardiosave Hybrid Intra-Aortic Balloon Pump systems with specific model numbers. This recall is due to an update to the preventative maintenance schedule that aligns with changes in the service manual effective June 2023. The recall does not involve a safety hazard but requires updated maintenance procedures.

Why it’s dangerous

The recall involves updating the preventative maintenance schedule to match changes in the service manual that became effective in June 2023. This update ensures devices are maintained according to the latest manufacturer specifications without causing safety issues.

Who’s affected

Patients using Cardiosave Hybrid Intra-Aortic Balloon Pump systems with the listed model numbers and serial numbers are affected. Healthcare providers who maintain these devices are most at risk of missing critical maintenance updates.

How to tell if you have this one

Check for model numbers D998-00-0800-31 through D998-00-0800-65 or D998-UC-0800-31 through D998-UC-0800-55 on the device. All devices with the listed serial numbers are included in this recall.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Maintenance Schedule
Check the device's maintenance schedule against the updated service manual requirements effective June 2023.

✎ GovInfoNow

Questions people ask

Is this recall due to a safety hazard?

No, this recall is for updated preventative maintenance procedures, not a safety hazard.

Which model numbers are affected?

Model numbers D998-00-0800-31 through D998-00-0800-65 and D998-UC-0800-31 through D998-UC-0800-55 are affected.

Do I need to stop using the device?

No, the recall does not require stopping use but updating maintenance procedures.

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-0916-2026 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-0916-2026 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-0916-2026 (November 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0916-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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 Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Lower-risk recall