Device product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Z-2309-2021
Product summary
- Event
- Event 88334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-2309-2021
Official wording
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.
Code information: Lot: 82210399
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.
Derived failure modes
-
Unknown
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.