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.
FDA Recall Z-0001-2010 · Posted 2009-10-05
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Recalling FirmPenumbra Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-09-22
Date Terminated2010-11-24
Product Quantity2246 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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