Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., A
FDA device recall Z-2049-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Penumbra Inc.
- Reason for recall
- Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
- Action taken
- Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra. For further information, contact Penumbra, Inc. at 1-510-748-3223.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 9 units
- Distribution
- Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
- Date initiated
- 2009-07-02
- Date posted
- 2009-09-08
- Date terminated
- 2011-01-05
- Location
- Alameda, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEURON SELECT CATHETER SIZE 070 (K083125) | Penumbra, Inc. | 2008-11-21 |