Model note · Intra-aortic Balloon Pump
Arrow AutoCAT 2 series intra-aortic balloon pump, including AutoCAT 2 WAVE
The Arrow AutoCAT 2 is the IABP generation before Teleflex's AC3, and many units are still in hospital fleets. It merged four earlier Arrow pump technologies into one series with automatic timing and triggering (AutoPilot) and a manual Operator mode. The WAVE versions add fibre optic pressure sensing. It shares its therapy algorithms, bellows drive and battery recall history with the AC3, so the two are often serviced side by side.
The model
Maker, model and type.
- Maker
- Arrow International, Inc. (Teleflex Incorporated)
- Model
- AutoCAT 2 series intra-aortic balloon pump, including AutoCAT 2 WAVE (catalogue IAP-0400, IAP-0435, IAP-0500, IAP-0535)
- Device type
- Intra-aortic Balloon Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA clearance | K060309, AutoCAT Intra-Aortic Balloon Pump Series, cleared 6 April 2006; 21 CFR 870.3535, product code DSP, now Class II | Source |
| Predecessor technologies | AutoCAT (K983866), ACAT 1 (K965209), ACAT 2 (K002256) and the fibre optic sensor IAB black box (K021462) | Source |
| Pneumatic drive | Stepper motor driven bellows with augmented deflation and no disposable parts | Source |
| Pumping volume and balloons | 0.5 to 50 cc in 0.5 cc steps; for 30, 35, 40 and 50 cc balloons | Source |
| Battery | Sealed lead acid, at least 90 minutes, with an optional upgrade to double battery life | Source |
| Power | 85 to 265 V, 47 to 63 Hz; 225 W or 3.1 A | Source |
| Display and controls | 10.3 inch colour LCD with 26 backlit hard keys and no touchscreen | Source |
| Environment | Operating 5 to 45 degrees C (5 to 35 degrees C with fibre optic sensor); storage -15 to 40 degrees C, 200 to 1060 hPa, 15 to 80% humidity | Source |
| Software level in 2006 clearance | V2.22, with changes to AutoPilot timing, triggering, AP zero and calibration, purge cycle and helium refill, and alarm handling | Source |
Recalls
Known FDA recalls.
- Z-0426-20232022-10-17
Potential short battery run times (AutoCAT 2 IAP-0400; related records cover other regional variants).
FDA record - Z-2408-20202020-05-20
Motor connector wires susceptible to vibration damage, with System Error 3 and High Baseline alarms.
FDA record - Z-0550-20082007-11-12
Possible leak in the helium drive system (IAP-0400, IAP-0435, IAP-0500, IAP-0535).
FDA record
Sources
Where this note comes from.
- Teleflex IABP product page (EMEA, AC3 Optimus successor)
- FDA 510(k) K060309 summary, AutoCAT Intra-Aortic Balloon Pump Series
- FDA 510(k) K162820 summary, AC3 Series IABP (contains AutoCAT 2 comparison table)
- openFDA recall search, AC3 and AutoCAT
- openFDA MAUDE problem counts, brand AUTOCAT2
Not covered: Teleflex no longer has a dedicated AutoCAT 2 page, so the manufacturer link points to its successor. Most specifications come from the AutoCAT 2 column of the AC3 510(k) comparison table. Which catalogue numbers are WAVE versions was not confirmed. The operator and service manuals are not public, so only alarms named in recalls are listed. Teleflex may have announced end of service dates for AutoCAT 2; none were found in an opened source. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Intra-aortic Balloon Pump
Other models of this device.
Next