Model note · Intra-aortic Balloon Pump
Arrow AC3 Optimus intra-aortic balloon pump
The AC3 Optimus is Teleflex's current intra-aortic balloon pump. It is a touchscreen successor to the Arrow AutoCAT 2 and keeps the same core therapy algorithms. A stepper motor driven bellows shuttles helium into the balloon in diastole and pulls it out before systole. The Optimus version adds the FiberOptix sensor and the WAVE IntraBeat algorithm, which times inflation beat by beat, and an AutoPilot mode chooses trigger and timing automatically.
The model
Maker, model and type.
- Maker
- Arrow International, LLC (Teleflex Incorporated)
- Model
- AC3 Optimus intra-aortic balloon pump (IAP-0700 / IAP-0701; non fibre optic AC3 IAP-0600 / IAP-0601)
- Device type
- Intra-aortic Balloon Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Pneumatics | Stepper motor driven bellows; USP grade helium; disposable canister IAH-09045 (500 psi) or refillable cylinder IAH-09048 (2000 psi) | Source |
| Pumping volume and rate | 0.5 to 50 cc in 0.5 cc steps; 40 to 200 pulsations per minute; assist ratios 1:1, 1:2, 1:4, 1:8 | Source |
| Compatible balloons | 30, 35, 40 and 50 cc Arrow IAB catheters (UltraFlex, Ultra 8, NarrowFlex, RediGuard) | Source |
| Electrical | 90 to 264 VAC, 47 to 63 Hz; typical 3.7 A at 110 VAC, maximum 5.1 A at 110 VAC and 2.8 A at 240 VAC | Source |
| Battery | At least 90 minutes on full charge, 180 minutes with optional second battery; about 4 hours to recharge to 80% | Source |
| Size and weight | Control module 26 x 36.8 x 5.0 cm, 2.7 kg; pneumatic unit 84.6 x 33 x 62.2 cm, 44.5 kg; total 47.2 kg | Source |
| Display | 13.3 inch 1208 x 800 resistive touchscreen with 3 waveform channels (ECG, arterial pressure, balloon pressure) | Source |
| Trigger modes | ECG (Pattern, Peak, AFib; 50 microvolt minimum), arterial pressure (3 mmHg minimum pulse pressure), pacer (VPace, APace) | Source |
| Operating temperature | 0 to 45 degrees C without fibre optic sensor, 0 to 35 degrees C with it | Source |
| FDA classification | Intra-aortic balloon and control system, 21 CFR 870.3535, Class II, product code DSP; K162820 (decided 31 March 2017, predicate AutoCAT 2 K060309) | Source |
Recalls
Known FDA recalls.
- Z-0438-20232022-10-17
Potential short battery run times (AC3 Optimus IAP-0700; related records cover IAP-0701, AC3 and AutoCAT 2).
FDA record - Z-2416-20202020-05-20
Motor connector wires vulnerable to vibration damage, with System Error 3 and High Baseline alarms and possible sudden stop.
FDA record - Z-2417-20202020-05-20
Same motor connector issue for AC3 Optimus IAP-0701.
FDA record
Safety
Safety warnings from the record.
- A motor wiring fault can cause abrupt loss of counterpulsation or stop the pump starting. Source
- Short battery life puts patients at risk during transport between departments or facilities, which is part of the intended use. Source
- The fibre optic sensor lowers the maximum operating temperature to 35 degrees C. Source
Sources
Where this note comes from.
- Teleflex AC3 Optimus IABP product page (EMEA)
- Teleflex AC3 Optimus IABP specification sheet
- FDA 510(k) K162820 summary, AC3 Series IABP System
- openFDA recall search, AC3 and AutoCAT
- openFDA MAUDE problem counts, brand AC3 Optimus
Not covered: The operator manual (IAM-9010) and service manual are not publicly posted, so only alarms named in FDA recalls are listed and their full meanings are not confirmed. Later 510(k)s (K192238, K201112, K232343) were not reviewed in detail. The EMEA product page was not opened directly; specifications come from Teleflex's spec sheet and the FDA summary. MAUDE counts are reports, not failure rates. 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.
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