Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M,
FDA device recall Z-0001-2010 · posted 2009-10-05 · Terminated
Recall details
- Recalling firm
- Penumbra Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 2246 units
- Distribution
- Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
- Date initiated
- 2009-09-22
- Date posted
- 2009-10-05
- Date terminated
- 2010-11-24
- Location
- Alameda, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEURON DELIVERY CATHETER 070 (K082290) | Penumbra, Inc. | 2008-10-31 |