Campbell, CA, United States
Ostial Corporation recalls
1 recall recorded since 2018, most recently on 14 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 July 2021
- Terminated
- 30 January 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2309-2021
- FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.