FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Reported: August 8, 2018 Initiated: April 11, 2018 #Z-2569-2018
Product Description
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.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 968 units
- Distribution
- Nationwide
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size). Recalled by Stryker Neurovascular. Units affected: 968 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2569-2018.
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