Maquet Cardiosave Hybrid IABP Recall: Fluid Ingress Risk

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Recalling firmMaquet Datascope Corp - Cardiac Assist Division1300 Macarthur Blvd, N/A · Mahwah, NJ 07430-2052

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Maquet is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) that could stop therapy if fluids enter the device. This risk affects patients using the pump for heart support.

Why it’s dangerous

Fluids entering the device can damage electronic circuits, causing the pump to stop working. This could interrupt life-saving heart support for patients.

Who’s affected

Patients using the Cardiosave Hybrid IABP for heart support are most at risk. The recall applies to specific part numbers and serial numbers sold between March 2012 and April 2018.

How to tell if you have this one

Check the part number on the pump (0998-00-0800-XX or 0998-UC-0800-XX) and the serial number. The recall covers units sold from March 6, 2012, to April 26, 2018.

Brand
Maquet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Part Number
Look for part numbers 0998-00-0800-XX or 0998-UC-0800-XX on the pump.
Contact Manufacturer
Reach out to Maquet Datascope Corp for specific guidance on next steps.

✎ GovInfoNow

Questions people ask

Why is this pump being recalled?

Fluids entering the device can damage electronic circuits, preventing the pump from working properly and interrupting life-saving heart support.

What part numbers are affected?

Part numbers 0998-00-0800-XX and 0998-UC-0800-XX (excluding specific numbers listed in the recall).

When were these pumps sold?

Sold from March 6, 2012, to April 26, 2018.

Take action

Contact Maquet

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

✉️ Open in email

Subject: Recall Z-1928-2018 — Maquet Maquet

Hello,

I own a Maquet that is covered by recall Z-1928-2018 from Maquet.

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-1928-2018 (May 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1928-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding

Use caution until it’s fixed