FlowGate Balloon Guide Catheter recall
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&quot…
Why was FlowGate Balloon Guide Catheter recalled?
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
- Product
- FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&quot…
- Recalling firm
- Concentric Medical Inc
- Quantity
- 13 units
- Distribution
- US (nationwide) including the states of CA, FL, GA, OR and TN.
- Recall date
- January 16, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)