Recall Z-2309-2021— Ostial Corporation

Name: FDA recall Z-2309-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-14

Class II · Terminated

Class II FDA medical device recall by Ostial Corporation, initiated 2021-07-14, terminated 2024-01-30. It names one FDA 510(k) clearance: K122379. Product: FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA. Reason: 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..

Recalling firm: Ostial Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-07-14
Terminated: 2024-01-30
Firm location: Campbell, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122379 — FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMOstial Corporation·cleared 2012-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.