Z-2309-2021 Class II Terminated
FDA device recall Z-2309-2021 was initiated by Ostial Corporation on July 14, 2021 and is designated Class II. 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. The recall status is terminated (terminated January 30, 2024). Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- July 14, 2021
- Termination Date
- January 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
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 Pattern
US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
Code Information
Lot: 82210399