FDA-Device2021-08-25Class II
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Ostial Corporation
Hazard
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.
Sold states
US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
Affected count
40
Manufactured in
197 E Hamilton Ave Ste 101, N/A, Campbell, CA, United States
Products
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2021Don't want to check this manually?
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