FDA Device recall Z-0655-2013
FlowGate Balloon Guide Catheter
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of FlowGate Balloon Guide Catheter by Concentric Medical, citing firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-20 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Concentric Medical |
| Distribution | US |
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
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Identifiers
| code_info | Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.