# K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Aug 11, 2003 after 76 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 8 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965236 (1997). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
7 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965236: System 96 Intra-Aortic Balloon Pump (Iabp), Datascope Corp. (1997) Summary page 1.
- K983866: Belmont Model Ngpbp Intra-Aortic Balloon Pump, Belmont Instrument Corp. (2000) Summary page 1.

## Most influential descendants
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), 2 descendants of its own
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (2015), 1 descendant of its own
- K181122: CARDIOSAVE Intra-Aortic Balloon Pump (2018), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1486-2026: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- Jul 17, 2017 · Class I · Z-3086-2017: 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.
- Jul 17, 2017 · Class I · Z-3085-2017: 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.
- Jun 16, 2017 · Class I · Z-2737-2017: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the fai
- Jun 16, 2017 · Class I · Z-2736-2017: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the fai
- Mar 21, 2014 · Class I · Z-1523-2014: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
- Mar 16, 2011 · Not classified · Z-2414-2011: Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.
- May 10, 2010 · Not classified · Z-1811-2010: Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issue

## Indications for use
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.

Source page: https://510kreport.com/device/K031636
Methodology: https://510kreport.com/methodology