The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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 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…
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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