# FDA recall Z-0441-2023

> **ARROW INTERNATIONAL Inc.** · Class I · device recall initiated 2022-10-17.

## Product

Arrow AC3 Optimus Intra-Aortic Balloon Pump,  AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113),   cardiac pump

## Reason for recall

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0441-2023
- **Recalling firm:** ARROW INTERNATIONAL Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-17
- **Report date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2023

## Citation

> AI Analytics. FDA recall Z-0441-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0441-2023. Source: US FDA. Licensed CC0.

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