Agency classClass IOur severity:Severe FDA (Devices)·Z-3086-2017·Announced 2017-09-13

Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects

Maquet Datascope is recalling 14,547 CS 100 Intra-Aortic Balloon Pumps worldwide due to a defect that could prevent therapy initiation or continuation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the recall as FDA Class I. According to the severity rubric, FDA Class I recalls are assigned a score of 4 (Severe) or higher, and the rule states that if the agency's classification is FDA Class I, the score must never go below 4.

Plain-English summary

Maquet Datascope Corp - Cardiac Assist Division is recalling 14,547 units of the CS 100 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 defect involving false blood back detection alarms and the ingress of fluids into the device. These issues can affect various electronic circuit boards, which could potentially prevent the initiation or continuation of therapy. The CS 100 Intra-Aortic Balloon Pump is a medical device designed to support the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work.

The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this defect. The recall is classified as Class I by the FDA.

The recalled product

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…
Manufacturer: Maquet Datascope Corp - Cardiac Assist Division
Category: Medical Device — Cardiac Assist Device
Hazard: electronic-defect
therapy-interruption

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-3013-XX
0998-UC-3013-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 →

Same manufacturer · Maquet Datascope Corp - Cardiac Assist Division

See all →

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FDA (Devices) · 2018-11-07
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Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
FDA (Devices) · 2018-06-06
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Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk
FDA (Devices) · 2017-09-13
Severe
Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
FDA (Devices) · 2017-09-13

Same hazard · electronic defect