Z-0655-2013Class II

FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA...

Name: Z-0655-2013 FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA...
Creator: Concentric Medical Inc
Published: 2012-12-20
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2012-12-20 / Terminated / root cause: design

FDA source

Concentric Medical Inc began a recall of FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp;quot; Balloon Guide Catheters are coaxial-lumen... on 2012-12-20. FDA classified it as Class II and gives the reason as "Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0655-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-01-08
Terminated: 2013-02-05
Recalling firm: Concentric Medical, Inc.
Product: FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp;quot; 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&amp;quot; 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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: design
FDA root cause: Device Design
Action: Concentric Medical sent a Urgent Medical Device Recall Notification letter dated December 19, 2012, to all affected customers. The letter identified the product the problme and the action needed to be taken by the customer. Customers were instructed to follow these instructions. 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Concentric Medical (Stryker Neurovascular) can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: Fax it to: 650-237-5230 Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Upon receipt of the returned customer response form, a Stryker Representative will contact you to arrange for credit of returned devices. On behalf of Stryker Neurovascular, we sincerely thank you for your help and support and regret any inconvenience and appreciate your assistance in completing this recall. Should you have any questions concerning this matter please do not hesitate to contact the undersigned.
Quantity in commerce: 13 units
Distribution: US (nationwide) including the states of CA, FL, GA, OR and TN.
Product codes and lots: Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0655-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0655-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-08

Product code DQY

K122581Class IIModified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. / cleared 2012-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-06. View this recall on fda.gov (opens on fda.gov)