FDA recall Z-2569-2018

Product

FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)

Reason for recall

There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-04-11

Report date

2018-08-08

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2569-2018