FLASH Ostial System recall
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Why was FLASH Ostial System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 82210399
- Product
- FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
- Recalling firm
- Ostial Corporation
- Quantity
- 40
- 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.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)