# FDA recall Z-2409-2020

> **Arrow International Inc** · Class I · device recall initiated 2020-05-20.

## Product

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

## Reason for recall

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 fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for  System Error 3  and  High Baseline  presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2409-2020
- **Recalling firm:** Arrow International Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-20
- **Report date:** 2020-07-08
- **Termination date:** 2023-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2020

## Citation

> AI Analytics. FDA recall Z-2409-2020. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2409-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*