# FDA recall Z-0716-2020

> **Arrow International Inc** · Class II · device recall initiated 2019-11-15.

## Product

Arrow Berman Angiographic Catheter 60cm  Item Number:   AI-07130-J

## Reason for recall

Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by  attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

## Distribution

U.S. Nationwide, Canada

## Key facts

- **Recall number:** Z-0716-2020
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2019-12-25
- **Termination date:** 2020-06-19

- **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-0716-2020

## Citation

> AI Analytics. FDA recall Z-0716-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0716-2020. Source: US FDA. Licensed CC0.

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