Datascope Cardiosave Hybrid IABP Pumps: Autofill Failure Risk

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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 certain Cardiosave Hybrid Intra-Aortic Balloon Pumps because users may identify autofill failure conditions that cause the pumps to stop working. This could lead to medical complications if the pump fails during use.

Why it’s dangerous

The pumps may stop working due to autofill failure conditions that users identify. This could lead to inadequate cardiac support if the pump stops during critical medical procedures.

Who’s affected

Healthcare professionals using these pumps for cardiac support are most at risk. Patients receiving this device may experience complications if the pump stops unexpectedly.

How to tell if you have this one

Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and other listed models. The unique device identifier (UDI) codes are also listed for each model.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the pump to see if it matches the recalled list of part numbers.
Contact Manufacturer
Reach out to Datascope Corp. for further assistance if you have a recalled pump.

✎ GovInfoNow

Questions people ask

What part numbers are affected?

Part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and others listed in the recall notice.

How can I tell if my pump is recalled?

Check the pump's model number against the list of part numbers provided in the recall notice.

Is there a fix for this issue?

The recall notice does not specify a remedy or fix for this issue.

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-2437-2023 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-2437-2023 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-2437-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2437-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,

Use caution until it’s fixed