FDA recall Z-2309-2021

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-07-14

Report date

2021-08-25

Termination date

2024-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Campbell, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2021