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.
FDA Recall Z-2049-2009 · Posted 2009-09-08
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Recalling FirmPenumbra Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-07-02
Date Terminated2011-01-05
Product Quantity9 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
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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