Recall Z-2049-2009 ยท DQY Catheter, Percutaneous
Penumbra Inc.
Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
| Date | Sep 8, 2009 (initiated Jul 2, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 9 units |
| Distribution | Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083125 | NEURON SELECT CATHETER SIZE 070 Penumbra, Inc., Nov 21, 2008 |