FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
FDA device recall Z-2569-2018 · posted 2018-07-28 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 968 units
- Distribution
- Nationwide
- Date initiated
- 2018-04-11
- Date posted
- 2018-07-28
- Date terminated
- 2021-04-28
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8F FlowGate2 Balloon Guide Catheter (K153729) | Concentric Medical | 2016-01-27 |