FlowGate Balloon Guide Catheter — Class II medical device recall Z-0655-2013
Terminated recall by Concentric Medical Inc, reported 2013-01-16, distributed nationwide. Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide C
| Recall number | Z-0655-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Concentric Medical Inc, Mountain View, CA, United States |
| Recall initiated | 2012-12-20 |
| Classified | 2013-01-08 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2013-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Lot numbers | 36009, 36135, 36140 |
| Model numbers | 90253, 90254 |
Product
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Reason for recall
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0655-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.