Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect
Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential procedural delay due to device resistance but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling 968 units of the FlowGate2 Balloon Guide Catheter, specifically UPN 90485 (8Fx85cm) and 90495 (8Fx95cm). The recall is due to a potential manufacturing defect where the outer diameter of the balloon catheter may exceed the defined specifications.
The affected lots are 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, and 3941. These devices were distributed nationwide. If a user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device used, which could potentially prolong a procedure.
Healthcare providers should check their inventory for these specific lot numbers and sizes. If the device is in use and resistance is encountered, it should be removed and replaced with a new device.
The recalled product
- Product
- FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
- Manufacturer
- Stryker Neurovascular
- Affected units
- 968
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lots 1352
- 1630
- 1631
- 1802
- 1970
- 2652
- 2653
- 2654
- 2655
- 2656
- 2657
- 2658
- 2659
- 3169
- 3940
- 3941
Distribution
Distributed nationwide across the United States.
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