# K060309: Autocat Intra-Aortic Balloon Pump Series - Pathway: 510(k) (Special) - Applicant: Arrow Intl., Inc. - Decided: Apr 6, 2006 after 58 days - Product code: DSP (System, Balloon, Intra-Aortic And Control) - Device class: 2 - Regulation: 21 CFR 870.3535 - Recalls of this device: 29 (28 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K905313 (1991). 14 ancestors in all. 14 later devices descend from it; 3 cite it directly. 12 of 29 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K983866: Belmont Model Ngpbp Intra-Aortic Balloon Pump, Belmont Instrument Corp. (2000) Summary page 5. - K965209: Acat 1 (Arrow Cardiac Assist Technology 1), Arrow Intl., Inc. (1998) Summary page 5. - K002256: Arrow Acat 2 Intra-Aortic Balloon Pump, Arrow Intl., Inc. (2001) Summary page 5. - K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840, Arrow Intl., Inc. (2002) Summary page 5. ## 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 - K162820: AC3 Series IABP System (2017), 4 descendants of its own - K192238: AC3 Series Intra-Aortic Balloon Pump (IABP) (2019), 3 descendants of its own - K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own - K201112: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (2020), 2 descendants of its own ## Recalls of this device - Oct 17, 2022 · Class I · Z-0446-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0450-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0453-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0426-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0430-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0431-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0445-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0447-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0454-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0455-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0432-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0448-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0427-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0428-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0451-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0429-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0452-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0444-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0449-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - Oct 17, 2022 · Class I · Z-0456-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. - May 20, 2020 · Class I · Z-2415-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2413-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2408-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2411-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2412-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2414-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2410-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - May 20, 2020 · Class I · Z-2409-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret - Nov 12, 2007 · Not classified · Z-0550-2008: Leak may occur in the helium drive system for the IABP ## Indications for use The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure Source page: https://510kreport.com/device/K060309 Methodology: https://510kreport.com/methodology