Maquet Datascope CS 300 Intra-Aortic Balloon Pump Recall: Device Failed to Pump
Maquet Datascope recalls CS 300 Intra-Aortic Balloon Pumps that failed to pump due to electrical test failures, linked to patient deaths. Affected units have specific model numbers.
Stop using this now
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Contact the company
What happened, in plain English
Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps that failed to pump properly, which has been associated with patient deaths. This recall affects specific model numbers and requires immediate attention. Read more at govinfonow.com/recall/73831-maquet-datascope-cs-300-intra-aortic-balloon-pump-recall-device.
Source Summary by GovInfoNow · govinfonow.com/recall/73831-maquet-datascope-cs-300-intra-aortic-balloon-pump-recall-device · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2738-2017
Cite this page
“Maquet Datascope CS 300 Intra-Aortic Balloon Pump Recall: Device Failed to Pump.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73831-maquet-datascope-cs-300-intra-aortic-balloon-pump-recall-device. Based on FDA recall #Z-2738-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2738-2017%22&limit=1).
Why it’s dangerous
The pump fails to pump due to electrical test failures, including a power-up vent test failure and autofill issues. These failures have been linked to patient deaths because the device cannot initiate therapy when needed.
Who’s affected
Medical professionals using the CS 300 Intra-Aortic Balloon Pump for cardiac support are most at risk. Patients receiving this device could face life-threatening complications if the pump fails.
How to tell if you have this one
Check for model numbers 0998-XX-3023-XX or 0998-UC-3023-XX on the pump. The recall applies to specific units sold by Maquet Datascope.
- Brand
Maquet Datascope- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Worldwide Distribution - (in over 100 countries) US (Nationwide)
| Recall number | Product, codes & lots |
|---|---|
| Z-2736-2017 | CS 100i Intra-Aortic Balloon Pump; 0998-UC-0446HXX 0998-UC-0479HXX |
| Z-2737-2017 | CS 100 Intra-Aortic Balloon Pump; 0998-XX-3013-XX, 0998-UC-3013-XX |
| Z-2738-2017 | CS 300 Intra-Aortic Balloon Pump; 0998-XX-3023-XX 0998-UC-3023-XX |
What to do — step by step
Stop Using It Now
Immediately stop using the CS 300 Intra-Aortic Balloon Pump if it is malfunctioning or has been recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - (in over 100 countries) US (Nationwide)” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2738-2017 (June 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2738-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.