The Recall Desk
HighFDA (Devices)·Z-3087-2017·Announced 2017-09-13

Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk

Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps because fluid ingress could damage electronic boards, potentially preventing therapy initiation or continuation.

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 the defect could prevent the initiation or continuation of critical cardiac therapy, representing a risk of harm even though specific injuries or illnesses are not reported in the source text.

Plain-English summary

Maquet Datascope Corp - Cardiac Assist Division is recalling 14,547 units of the CS 300 Intra-Aortic Balloon Pump. The recall covers 5,049 units distributed domestically in the United States and 9,498 units distributed internationally across numerous countries.

The recall is due to a potential defect where false blood back detection alarms and the ingress of fluids into the device could affect various electronic circuit boards. This issue could potentially prevent the initiation or continuation of therapy for patients using the device.

The CS 300 Intra-Aortic Balloon Pump is a medical device that supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Users should contact the manufacturer for further instructions regarding the recall and replacement or repair of affected units.

The recalled product

Product
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 p
Manufacturer
Maquet Datascope Corp - Cardiac Assist Division
Category
Medical Device — Cardiac Assist Device
Hazard

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-XX-3023-XX
  • 0998-UC-3023-XX

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.

See all 3 products in this recall →

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