# FDA recall Z-2309-2021

> **Ostial Corporation** · Class II · device recall initiated 2021-07-14.

## Product

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

## Reason for recall

Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.

## Distribution

US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.

## Key facts

- **Recall number:** Z-2309-2021
- **Recalling firm:** Ostial Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-14
- **Report date:** 2021-08-25
- **Termination date:** 2024-01-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Campbell, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2021

## Citation

> AI Analytics. FDA recall Z-2309-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2309-2021. Source: US FDA. Licensed CC0.

---

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