FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
This recall has been terminated (originally issued July 28, 2018).
- Company
- Stryker Neurovascular
- Recall Initiated
- April 11, 2018
- Posted
- July 28, 2018
- Terminated
- April 28, 2021
- Recall Number
- Z-2569-2018
- Quantity
- 968 units
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
Root Cause
Employee error
Action Taken
On April 12, 2018, the recalling firm sent Urgent Medical Device Voluntary Customer Communication, Immediate Action Required letters with instructions to return a response form. The letter provided directions for use.