Ostial Corporation: Medical Device Recall in 2021 - (Recall #: Z-2309-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 14, 2021

Date Posted: August 25, 2021

Recall Number: Z-2309-2021

Event ID: 88334

Reason for Recall:

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.

Status: Terminated

Product Quantity: 40

Code Information:

Lot: 82210399

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated