Recall Z-0001-2010 ยท DQY Catheter, Percutaneous
Penumbra Inc.
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| Date | Oct 5, 2009 (initiated Sep 22, 2009) |
| Status | Terminated |
| Reason | Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient. |
| Root cause | Device Design |
| Action | The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form. |
| Quantity | 2246 units |
| Distribution | Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082290 | NEURON DELIVERY CATHETER 070 Penumbra, Inc., Oct 31, 2008 |