Agency classClass IOur severity:Severe FDA (Devices)·Z-3085-2017·Announced 2017-09-13

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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

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
Hazard: fluid-ingress
electronic-failure
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-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.

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 Cardiosave Rescue IABP Recalled for High Altitude Therapy Interruption
FDA (Devices) · 2018-11-07
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Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
FDA (Devices) · 2018-06-06
Severe
Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects
FDA (Devices) · 2017-09-13
Severe
Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk
FDA (Devices) · 2017-09-13

Same hazard · fluid ingress