Z-0899-2011

Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by...

Name: Z-0899-2011 Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by...
Creator: Concentric Medical Inc
Published: 2009-02-27
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2009-02-27 / Terminated / root cause: manufacturing process

FDA source

Concentric Medical Inc began a recall of Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA... on 2009-02-27. The reason FDA records is "Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0899-2011
Status: Terminated
Initiated: 2009-02-27
Posted: 2011-01-12
Terminated: 2011-01-13
Recalling firm: Concentric Medical, Inc.
Product: Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is 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. Not intended for use to deliver embolic agents or to perform angioplasty.
Product code: GBS Catheter, Ventricular, General & Plastic Surgery
Reason for recall: Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and identify any affected product. Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices. For questions regarding this recall call 877-471-0076.
Quantity in commerce: 36 units affected.
Distribution: Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
Product codes and lots: Lot numbers 33367 and 33407

Product code GBS

K021899Class IIConcentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. / cleared 2002-07-10

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)