Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
Maquet Datascope is recalling 14,547 CS 100i Intra-Aortic Balloon Pumps because fluid ingress and false alarms could prevent therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could prevent the initiation or continuation of life-support therapy, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling 14,547 units of the CS 100i Intra-Aortic Balloon Pump. The recall covers 5,049 units distributed domestically and 9,498 units distributed internationally.
The recall is due to a potential for false blood back detection alarms and the ingress of fluids into the device. These issues could affect various electronic circuit boards, potentially preventing the initiation or continuation of therapy.
The affected devices were distributed worldwide, including across the United States and numerous international locations. The specific product codes involved are 0998-UC-0446HXX and 0998-UC-0479HXX.
The recalled product
- Product
- 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
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 0998-UC-0446HXX
- 0998-UC-0479HXX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Maquet Datascope Corp - Cardiac Assist Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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