Maquet Datascope CS 1: False Blood Detection May Prevent Heart Therapy
Maquet Datascope recalls CS 100 Intra-Aortic Balloon Pumps due to false blood back detection alarms and fluid ingress that could stop heart support therapy.
Use caution until it’s fixed
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
Contact the company
What happened, in plain English
Maquet Datascope recalls CS 100 Intra-Aortic Balloon Pumps because faulty alarms and fluid leaks might stop the device from supporting heart function. This could lead to serious health risks for patients using the pump. Read more at govinfonow.com/recall/73406-maquet-datascope-cs-1-false-blood-detection-may-prevent-heart.
Source Summary by GovInfoNow · govinfonow.com/recall/73406-maquet-datascope-cs-1-false-blood-detection-may-prevent-heart · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3086-2017
Cite this page
“Maquet Datascope CS 1: False Blood Detection May Prevent Heart Therapy.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73406-maquet-datascope-cs-1-false-blood-detection-may-prevent-heart. Based on FDA recall #Z-3086-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3086-2017%22&limit=1).
Why it’s dangerous
The pump's false blood back detection alarm and fluid leaks can disrupt the device's ability to support the heart. This might cause the pump to stop working during critical moments, risking inadequate heart support.
Who’s affected
Patients using the CS 100 Intra-Aortic Balloon Pump for heart support are most at risk. The device is used in medical settings for critical heart conditions.
How to tell if you have this one
The CS 100 Intra-Aortic Balloon Pump is used in medical settings. Look for model numbers 0998-XX-3013-XX or 0998-UC-3013-XX.
- 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
Ongoing- Distribution
Worldwide Distribution - US Nationwide International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS, NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM & YEMEN.
| Recall number | Product, codes & lots |
|---|---|
| Z-3085-2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.; 0998-UC-0446HXX; 0998-UC-0479HXX |
| Z-3086-2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.; 0998-XX-3013-XX; 0998-UC-3013-XX |
| Z-3087-2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.; 0998-XX-3023-XX; 0998-UC-3023-XX |
What to do — step by step
Check Device Function
Ensure the pump is working properly by observing for false alarms or unusual sounds.
Contact Manufacturer
Reach out to Maquet Datascope for guidance on next steps if issues are detected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA,…” 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 published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the pump immediately?
The recall does not require immediate stoppage; however, monitoring for issues and contacting the manufacturer is advised.
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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-3086-2017 (July 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3086-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.