FDA Device recall Z-3086-2017
CS 100 Intra-Aortic Balloon Pump
- FDA Device
- Class I
- ongoing
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class I recall of CS 100 Intra-Aortic Balloon Pump by Maquet Datascope Cardiac Assist Division, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3086-2017 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2017-07-17 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | 0998-XX-3013-XX; 0998-UC-3013-XX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3086-2017%22
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