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Ostial Corporation recalls FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Recalled August 25, 2021 · FDA recall Z-2309-2021 · Ostial
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. · FDA Class II
Units
40
Sold at
US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
Description
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.
Product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Manufacturer(s)
Ostial Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →