medical Class II Updated 2021-08-25

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 82210399
View official government recall

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