Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric
FDA device recall Z-0899-2011 · posted 2011-01-12 · Terminated
Recall details
- Recalling firm
- Concentric Medical Inc
- Reason for recall
- Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GBS
- Quantity affected
- 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
- Date initiated
- 2009-02-27
- Date posted
- 2011-01-12
- Date terminated
- 2011-01-13
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 (K021899) | Concentric Medical, Inc. | 2002-07-10 |