Ostial Corporation recalls FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Recall date

July 14, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2309-2021

FDA classification

Class II

Brand / firm

Ostial Corporation

Sold / distributed

US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA